HNCA advises all patients to discuss available Clinical Trials with their medical team. All studies were collected from ClinicalTrials.gov. The information included on this page is for informational purposes only. More clinical trials can be found using our Clinical Trial Finder which is designed to be user-friendly for patients.

  • Featured Clinical Trial

    Image for MeriaGTx radiation-induced xerostomia clinical trial

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Head and Neck Cancer Focused Trials

Image for Checkmate Pharmaceuticals' CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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Image for Rakuten's clinical trial ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

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Image for VERSATILE-002 - A PDS Biotechnology Trial in Head & Neck Squamous Carcinoma Cancer

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Image for Merck's head and neck cancer clinical trials, enrolling people with head and neck cancer for a varieryt of trials. Learn more

HNCA advises all patients to discuss available Clinical Trials with their medical team.

See if you qualify!


RTX-321 Monotherapy in Patients With HPV 16+ Tumors

Conditions: Cervical Cancer, Anal Cancer, Head and Neck Cancer

This is an open-label, multicenter, multiple-ascending dose, first in human, Phase 1 study of RTX-321 for the treatment of patients that are HLA-A*02:01 positive with persistent, recurrent, or metastatic, unresectable, HPV 16+ cancers, including cervical cancer, anal cancer, and head and neck cancer (including nasal cavity cancer, oral cancer, laryngeal cancer, hypopharyngeal cancer, nasopharyngeal cancer, and oropharyngeal cancer).

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CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Conditions: Carcinoma, Squamous Cell of Head and Neck

CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody.

The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC)

The secondary objectives are to:

  • To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC
  • To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC
  • To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab

Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.

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“QUAD SHOT” Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer

Conditions: Head and Neck Cancer

The purpose of this study is to test the safety of palliative “QUAD SHOT” radiotherapy combined with pembrolizumab and evaluate the effects of the combination treatment patients with recurrent cancer of head and neck.

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1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck

Conditions: Squamous Cell Carcinoma

This phase II single arm study is being done to determine if bavituximab could potentially synergize with PD-1 inhibitor therapy to generate an effective anti-tumor immune response in patients with recurrent/metastatic squamous cell head and neck cancer (HNSCC) who progressed on a PD-1 inhibitor.

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A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Conditions: Squamous Cell Carcinoma of Head and Neck

This is a multicenter, open-label, two arms, randomized, phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).

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A Comprehensive Approach to Head and Neck Cancer Prehabilitation

Conditions: Cancer of Head and Neck

Head and neck cancer accounts for 3% of malignancies in the United States. However, the diagnosis and treatment for head and neck cancer is considered to be debilitating. Not because of its morbidity, but due to the extremely rigorous treatment course which has a profound impact on patients physical, social, and emotional functioning. Disfigurement and sensorimotor deficits further compound this impact. Head and neck cancer patients contend with treatments that can significantly affect their quality of life. Treatment regularly results in decreased functional capacity and decreased quality of life. Physical impairments are manifested through, but not limited to, disfigurement, deconditioning, communication issues, “swallowing, speech, breathing, and cancer-related fatigue”. Premorbid factors such as preexisting anxiety and depression, chemical dependency, financial barriers, and lack of social support system are unique obstacles to the head and neck cancer population impacting treatment and outcomes. Due to these factors, patients experience higher rates of anxiety and depression, psychological distress, and fear of cancer recurrence. In fact, “compared with other survivors of cancer, head and neck cancer survivors are almost 2 times more likely to die from suicide”. In view of the aforementioned research, Roger Maris Cancer Center’s head and neck cancer will implement a prehabilitation program that evaluates each patient using standardized screening tools and provide personalized education and interventions. This project evaluates a more comprehensive and proactive multidisciplinary approach to improve treatment and outcomes in head and neck cancer patients.

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A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery

Conditions: Head and Neck Carcinoma

This trial studies examines the impact of virtual reality (VR) experiences and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. Virtual reality has shown to help rehabilitation and pain control primarily in non-surgical fields, and researchers are interested in using this to help postoperative pain control. Early mobilization after surgery is also important, and may increase lung capacity, improve gastrointestinal function, reduce pain, and reduce risk of deep venous thrombosis. Use of virtual reality and Fitbit devices may improve postoperative pain control and reduce narcotic use among hospitalized patients after head and neck surgery.

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A Dye for the Detection of Cancer of the Tongue and Mouth

Conditions: Oral Squamous Cell Carcinoma (OSCC)

The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.

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A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)

Conditions: Head and Neck Cancer

This randomized, non-blinded, phase 0/I study will assess the feasibility of conducting a large randomized clinical trial to evaluate the efficacy of the ePVA to improve pain management and HRQoL in HNC. Thirty participants undergoing radiation therapy (RT) (with or without chemotherapy) will be randomized to: 1) ePVA intervention or 2) usual care. The intervention consists of participants completing the ePVA every other week during radiation therapy (RT), then weeks 4, 12, and 24 after end of RT. Automated reports of ePVA data, including pain reports and patient-reports of pain medications, will be sent to providers to inform their clinical decisions.

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A Motion Exergaming Approach for Symptom Management: HNC

Conditions: Head and Neck Cancer

This overall objective of the RCT is to test an intervention to overcome the PA barriers for head and neck cancer (HNC) patients during the first 6 months after their treatment. PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Nintendo Switch). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data.

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A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients

Conditions: Head and Neck Cancer

This study has been designed to evaluate the safety and efficacy of giving seven injections of PepCan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.

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A Pilot Study Assessing Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck

Conditions: Oropharyngeal Neoplasms, Head and Neck Cancer

This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

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A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study

Conditions: Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck

A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in order to potentially improve progression free survival in a squamous cell carcinoma of the head and neck cohort at high-risk for recurrence.

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A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer

Conditions: Head and Neck Cancer, Head Cancer, Head Cancer Neck, Neck Cancer, Head and Neck Squamous Cell Carcinoma, HNSCC

The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.

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A Study of Debio 1143 (Xevinapant) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy

Conditions: Carcinoma, Squamous Cell of the Head and Neck

The primary objective of the study is to demonstrate superior efficacy of Debio 1143 vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

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A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

Conditions: Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer, Soft Tissue Sarcoma

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

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A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)

Conditions: Squamous Cell Carcinoma of Head and Neck

The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.

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A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)

Conditions: Head and Neck Squamous Cell Carcinoma

“This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

Hypotheses include:

  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).”

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A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol)

Conditions: Squamous Cell Carcinoma of Head and Neck

“The is a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.

Substudy 1-Cohort A1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who are treatment-naïve for recurrent and/or metastatic (R/M) disease.

Substudy 2 – Cohort A2 aims to establish proof-of-concept that SAR444245 combined with both the anti-PD1 antibody pembrolizumab and cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who are treatment-naïve for recurrent and/or metastatic (R/M) disease.

Substudy 4-Cohort B1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen.

Substudy 5-Cohort B2 aims to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen & cetuximab-naïve after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.”

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A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer

Conditions: Solid Tumor, Adult, Squamous Cell Carcinoma of Head and Neck, Colorectal Adenocarcinoma, Metastatic Solid Tumor, Recurrent Solid Tumor, Head and Neck Cancer

This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.

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Active Surveillance of Papillary Thyroid Microcarcinoma

Conditions: Papillary Thyroid Microcarcinoma

The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.

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Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer

Conditions: Head and Neck Squamous Cell Carcinoma, Malignant Solid Neoplasm

This phase I/II trial investigates the best dose and effect of alisertib in combination with pembrolizumab in treating patients with Rb-deficient head and neck squamous cell cancer. Alisertib may help block the growth of cancer.. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving alisertib in combination with pembrolizumab may help control Rb-deficient head and neck squamous cell cancer. HPV positive head and neck cancers are Rb-deficient.

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Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC

Conditions: HNSCC

This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.

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An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma

Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.

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ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

Conditions: Head and Neck Cancer

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician’s Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy

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Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.

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BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

Conditions: Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer

This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (CPS ≥ 1).

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Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma

Conditions: Head and Neck Cancer

This trial will evaluate safety and efficacy of the combination of anti-PD1, NKTR-214, and palliative radiation therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Twenty-four participants will be enrolled to evaluate the efficacy of this combination.

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Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Second Primary Squamous Cell Carcinoma of the Head and Neck

This phase I/II trial studies the side effects and how well bintrafusp alfa and stereotactic body radiation therapy work in treating patients with head and neck squamous cell cancer that has come back (recurrent) or has occurred after having cancer in the past (second primary). Immunotherapy with bintrafusp alfa may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving bintrafusp alfa and stereotactic body radiation therapy may help to control recurrent head and neck squamous cell cancer.

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Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma

Conditions: Locally Recurrent Head and Neck Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Sinonasal Squamous Cell Carcinoma

This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally recurrent). Drugs used in chemotherapy, such as birinapant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. IMRRT uses thin beams of radiation of different intensities that are aimed at the tumor from many angles. This type of re-irradiation therapy reduces the damage to healthy tissue near the tumor. Giving birinapant with IMRRT may lower the chance of head and neck squamous cell carcinoma growing or spreading.

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Body Image After Head and Neck Cancer Treatment

Conditions: Head and Neck Cancer

This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program [BIHNC]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete.

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Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0

Conditions: Head and Neck Cancer

“HNC survivors with BID will be randomized to 5-weeks of tablet-based BRIGHT (n=24) or tablet-based AC (electronic information about HNC recovery; n=24). Participants will complete the Body Image Scale (a validated measure of BID; primary outcome) and measures of psychological, social, and emotional wellbeing (secondary outcomes) at baseline, 1-week, and 1-month and 3-month post-intervention to assess the preliminary clinical impact of BRIGHT on BID in HNC survivors.

HNC survivors in BRIGHT or AC will complete the Body Image Coping Strategies Inventory (mediator; a validated measure of body image coping behavior) at baseline, 1-week, 1-month, and 3-months post-intervention to assess the role of image coping behavior as the behavioral mechanism of BRIGHT.”

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Cabozantinib in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Conditions: Head and Neck Squamous Cell Cancer, Recurrent Head and Neck Squamous Cell Cancer, Metastatic Head and Neck Squamous Cell Cancer

The purpose of this study is to test the safety of cabozantinib, at different doses, in combination with cetuximab to find out what effects, if any, this combined treatment has on people with HNSCC.

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Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery

Conditions: Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC

Conditions: Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck

The purpose of this research study is to determine how people with weakened immune systems and unresectable (cannot be removed by surgery) locally recurrent and/or metastatic cutaneous squamous cell carcinoma (CSCC) respond to study treatment with Cemiplimab. Cemiplimab is approved for sale in United States by the U.S. Food and Drug Administration (FDA).

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Central Pain Syndrome in Survivors of Head and Neck Cancer

Conditions: Head and Neck Cancer

This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.

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Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

Conditions: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma

This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.

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Cetuximab in Head and Neck Cancer Patients

Conditions: Head and Neck Cancer, Squamous Cell Carcinoma

This clinical trial is for participants with head and neck squamous cell carcinoma who are scheduled to have their tumor surgically removed. The study involves obtaining baseline tissue from a clinical biopsy or research biopsy and measurement of circulating tumor cells before surgery to determine whether AXL protein expression pre-treatment correlates to clinical outcomes (change in tumor size) after two doses of cetuximab. The importance of this study is to describe if AXL expression can be used as a biomarker to predict clinical response to cetuximab (CTX) treatment.

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Chemo-embolization for Head and Neck Cancer

Conditions: SCCHN, Squamous Cell Carcinoma

The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

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Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Conditions: Head and Neck Squamous Cell Carcinoma, Cancer, Cancer of Head and Neck, Cancer, Advanced, Cancer, Metastatic, Tumor, Tumor Recurrence, Tumor Neck, Tumor Metastasis, Oral Cancer, Oropharyngeal Cancer, Oropharynx Cancer, Oropharynx Cancer, Stage III, Oropharynx Cancer, Recurrent, Oropharynx Cancer, Metastatic

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

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CIML NK Cell in Head & Neck Cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck, Recurrent Head and Neck Squamous Cell Carcinoma

This research study is evaluating the safety and efficacy of a combination drug and biologic therapy in patients with advanced head and neck cancer.

This research study involves the following drugs and biologics:

  • CIML NK donor cells
  • IL-15 superagonist
  • Ipilimumab

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Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers

Conditions: Carcinoma, Squamous Cell, Head and Neck Cancer

Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reactive oxygen species generated by the drug in subjects with squamous cell carcinoma of the head and neck treated on this trial.

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CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Conditions: Carcinoma, Squamous Cell of Head and Neck

“CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody.

The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC)

The secondary objectives are to:

  • To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCCv
  • To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC
  • To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab
  • Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.”

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Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC

Conditions: HNSCC

Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive (CPS ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.

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Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Conditions: HNSCC

This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.

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Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

Conditions: Head and Neck Squamous Cell Carcinoma

The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

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Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer

Conditions: Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma, Advanced Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Unknown Primary

This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.

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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

Conditions: Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma, Hard Palate Squamous Cell Carcinoma, Lip Squamous Cell Carcinoma, Lower Alveolar Ridge Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Retromolar Trigone Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Tongue Squamous Cell Carcinoma, Upper Alveolar Ridge Squamous Cell Carcinoma

This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

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CONNECTing Head and Neck Caregivers to Supportive Care Resources

Conditions: Head and Neck Cancer

The purpose of this research is to determine feasibility and acceptability of randomized pilot trial to evaluate a technology-based intervention (CONNECT) to empower and educate caregivers about the benefits of supportive care resources, identify their unmet needs, and connect them with resources.

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Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Conditions: Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma

This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients’ mouth and cover patients’ teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.

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Dissecting the Heterogeneity of Oral Cancer Pain

Conditions: Oral Squamous Cell Carcinoma

“Oral squamous cell carcinoma (SCC) produces a higher prevalence and more severe pain than all other cancers. Orofacial pain is one of the most common initial symptoms of oral cancer and often leads to the diagnosis of oral cancer. However, the character, severity, and unique features of oral cancer widely differ between patients. There is currently no effective and lasting treatment available to alleviate suffering from oral cancer pain.

A significant obstacle to effectively treating cancer pain is that the relative contributions of nociceptive mediators and their mechanisms of action (i.e., responsible receptors) are largely unknown. There is, therefore, a critical need to define the neurobiologic mechanisms responsible for oral cancer pain. Without such information, the promise of non-opioid therapy for the treatment of oral cancer pain will remain unfulfilled.

The primary objective of this study is to define and quantify the phenotype of oral cancer pain in patients, by comparing mechano- and chemosensitivity in oral cancer patients with healthy subjects. Pain will be stimulated on the site of cancer in 40 oral cancer patients and on the tongue in 40 healthy volunteers utilizing chemical sensitivity and mechanical sensitivity tests.”

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Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer

Conditions: Head and Neck Neoplasm

“Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve therapeutic outcomes while limiting toxicities.

This protocol evaluates a novel framework for radiation delivery with concurrent atezolizumab in patients with advanced HNSCC. Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) modifies radiation dose using MRgRT by escalating radiation dose to residual tumor while deescalating radiation dose to areas of tumor regression.”

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Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck

Conditions: Squamous Cell Cancers of the Head and Neck

This is a single arm Phase II study for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who are previously treated with a platinum based regimen or with an immune checkpoint inhibitor. The primary objective is to evaluate the efficacy of the combination of cetuximab and afatinib.

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Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy

Conditions: Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites, Head and Neck Primary Squamous Cell Carcinoma

The goal of this clinical research study is to compare the results of a dual time point (standard and delayed) FDG PET/CT of the head and neck before and after chemo-radiation therapy.

This is an investigational study. The FDG PET/CT is delivered using FDA approved and commercially available methods. It is considered investigational to use delayed PET/CT scans to study the effects of chemo-radiation treatment.

The FDG injections and PET/CT scans (about 1 hour after FDG injection) will be done as part of your standard of care.

The delayed (about 3 hours after FDG injection) PET/CT scans will be provided at no cost to you.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

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Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

Conditions: Larynx, Lip, Oral Cancer, Digestive Organs–Diseases

The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, this investigational drug will be referred to as the “study drug”, or named individually (durvalumab). The study drug in this research is referred to as investigational because the U.S. Food and Drug Administration (FDA) has not yet approved itfor the treatment of head and neck cancer. Durvalumab was FDA approved in 2017 for the treatment of certain types of bladder cancer, but has not been approved for use in Head and Neck cancer patients.

Durvalumab is an experimental drug that uses the body’s immune system to fight the cancer. This study drug is being used in other ongoing clinical trials for other types of cancers. The doctor feels that a patient may experience fewer side effects using this study drug with radiation rather than using cisplatin. The doctor is also investigating whether using this drug can increase the effectiveness of treatment.

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Dyadic Yoga Intervention for the Improvement of Healthcare Utilization and Quality of Life in Patients With Head and Neck Cancer Undergoing Chemoradiation and Their Caregivers

Conditions: Head and Neck Carcinoma

This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.

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Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body

Conditions: Head and Neck Cancer

This trial studies how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) works in diagnosing osteoradionecrosis in patients with head and neck cancer that is primary, has come back, or has spread to other places in the body who are undergoing radiation therapy. DCE-MRI may help doctors to predict osteoradionecrosis in patient with head and neck cancer undergoing radiation therapy.

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Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC – Role of Gut Microbiome

Conditions: Head and Neck Cancer

This study aims to evaluate if eating within an 8-10-hour window during the day, without any caloric restriction, can lead to better response rates to immunotherapy in head and neck cancer patients.

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Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck

Conditions: Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.

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Enhanced Care Coordination for Head and Neck Cancer Survivors

Conditions: Head and Neck Cancer

The purpose of this study is to evaluate the effect of a multidimensional symptom management intervention on decreasing symptom burden and thus reducing hospital utilization in patients undergoing radiation with or without chemotherapy for head and neck cancer.

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Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial

Conditions: Oral Cancer, Oropharyngeal Cancer, Head and Neck Cancer

Project’s goal is evaluate an online tool the research team created called Empowered Survivor (ES) against a free online self-management intervention developed for cancer survivors by the National Cancer Institute and the American Cancer Society called Springboard Beyond Cancer.

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Evaluating Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

Conditions: Melanoma, Head and Neck Squamous Cell Carcinoma, Solid Tumor

A Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation, and cohort expansion study to examine the DLTs, MTD, and RP2D of SB 11285 administered as an IV infusion in patients with advanced solid tumors.

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Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

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Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment

Conditions: Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma, Maxillary Sinus Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Carcinoma, Paranasal Sinus Carcinoma, Sinonasal Carcinoma, Stage I Laryngeal Cancer AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Lung Carcinoma

This clinical trial evaluates the tolerability of a physical activity program in head and neck cancer patients who are undergoing cancer treatment. The goal of this trial is to give patients exercises prescribed by a physical therapist that they are able to complete regularly at home. Increasing physical activity may help patients reduce fatigue, improve mood, increase physical performance, and decrease joint pain.

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First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

Conditions: Head Neck Cancer, Metastatic Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Hypopharynx Squamous Cell Carcinoma, Larynx Squamous Cell Carcinoma

The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil

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Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery

Conditions: Head and Neck Neoplasm

This trial studies how well flexible intubation scope with or without video laryngoscope works in supporting endotracheal tube placement in patients with head and neck cancer before surgery. Flexible intubation scope and video laryngoscope are devices that have a small camera to help the doctor see the patient’s airway on a screen. Both devices may help the doctor who gives anesthesia prevent complications from placing the breathing tube (such as pain or mouth injury).

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Focused Ultrasound (FUS) Mesencephalotomy for Head & Neck Cancer Pain

Conditions: Cancer of Head and Neck, Pain, Face, Pain, Neck

This proposed pilot study will investigate the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer

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Hemopurifier Plus Pembrolizumab in Head and Neck Cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier to clear immunosuppressive exosomes in combination with pembrolizumab (Keytruda) in the front line setting, in patients with advanced and/or metastatic squamous cell carcinoma of the head and neck.

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HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer

Conditions: Head and Neck Neoplasms

The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.

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Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

“The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers in patients 70 years of age and older.

Standard radiation treatment for head and neck patients normally requires that the patient travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. If this happens, and there are gaps in the radiation treatment, this can lead to worse outcomes.”

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HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer

Conditions: Squamous Cell Carcinoma of Head and Neck

There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting.

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Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma, Locally Advanced Nasopharyngeal Squamous Cell Carcinoma, Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma, Malignant Posterior Tongue Neoplasm, Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Nasopharyngeal Carcinoma AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Unresectable Head and Neck Squamous Cell Carcinoma, Unresectable Oropharyngeal Squamous Cell Carcinoma

This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).

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Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer

Conditions: Head and Neck Cancer

CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-targeted therapy and to monitor response to such therapy. The investigators have developed a CCR2 specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i). The investigators have found that 64Cu-DOTA-ELC1i specific binding has been demonstrated in human head and neck cancer tissue.

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Immune Modulation by Abemaciclib in HNSCC. (AIM Trial)

Conditions: HNSCC

This is a randomized, parallel, open label Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).

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Implementation and Effectiveness Trial of HN-STAR

Conditions: Head and Neck Cancer

“People who have been treated for head and neck cancer (HNC survivors) can experience serious consequences from their cancer and its treatment, ongoing risks of new cancers, and other unrelated illnesses. These concerns pose challenges to the provision of comprehensive care to HNC survivors. We created HN-STAR to facilitate and tailor the ongoing care of HNC survivors. Survivors use HN-STAR on a computer or tablet to answer questions about symptoms and health concerns before a routine visit with a cancer care provider. During the clinic visit, the provider uses HN-STAR to see evidence-based recommendations for managing each concern reported by the survivor. The provider and survivor discuss recommendations and select appropriate actions (e.g., testing, referrals, prescriptions, self-management). HN-STAR produces a survivorship care plan that includes all reported concerns and the actions selected in clinic. The survivorship care plan is given to the survivor and the primary care provider. Three months, six months, and nine months later, the survivor uses HN-STAR from home (or clinic) to report their concerns again, and a new survivorship care plan is created each time.

Our trial randomizes ≥30 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 350 recent survivors of head and neck cancer. We hypothesize that survivors in the HN-STAR arm will have greater improvement in patient-centered outcomes (including cancer-related well-being, symptoms, and patient activation) over one year compared to survivors in the usual care arm, measured by surveys at baseline and one year later. We also hypothesize that survivors in the HN-STAR arm will be more likely to receive care that is aligned with evidence-based recommendations during the year of the study than survivors in the usual care arm. Our final aim investigates the implementation of HN-STAR in clinical practice, using interviews and surveys of survivors, providers, and other clinic staff to understand the feasibility, acceptability, appropriateness, and other aspects of providing survivorship care to head and neck cancer survivors.”

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Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer

Conditions: Head and Neck Cancer

This research is being performed to treat patient for head and neck cancer patients who have not received prior chemotherapy.

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Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating participants with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better at treating head and neck squamous cell cancer.

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Intratumoral Microdosing of Motolimod in HNSCC

Conditions: HNSCC

This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with nivolumab when administered intratumorally in microdose quantities via the CIVO device in patients with head and neck squamous cell carcinoma (HNSCC). CIVO stands for comparative in vivo oncology.

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Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer

Conditions: Head Neck Cancer

Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control trial (RCT) using mobile health technology to enhance adherence and improve swallowing outcomes in patients undergoing radiation therapy for head and neck cancer.

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Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Conditions: Squamous Cell Carcinoma of Head and Neck

This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

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Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Platin, 5-FU, Cetuximab, and Taxane

Conditions: Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck

No agent is known to have efficacy in patients with incurable HNSCC that progressed with prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this trial. Based on the preclinical and clinical data presented, the investigators propose that mitomycin C will have anti-tumor activity in these patients.

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Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region

Conditions: Squamous Cell Carcinoma of Head and Neck

This study will investigate the ability of Lucerno Dynamics Lara sensor when placed on the palpable carotid artery (or femoral artery) to monitor blood flow following the injection of 18-FDG and to distinguish peak flow in tumor versus tissue uptake. Investigators will then assess if differences in tumor versus tissue correlates with tumor response.

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MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Conditions: Mucositis Oral, Head and Neck Cancer

This study will examine if the administration of prophylactic MucoLox formulation versus sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ± chemotherapy will result in significantly fewer subjects experiencing severe mucositis.

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Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor

Conditions: Metastatic Head-and-neck Squamous-cell Carcinoma

“The primary hypothesis is that the objective response rate (ORR) with nab-paclitaxel and nivolumab will be significantly higher than the historical control (ORR 30%).

The KEY secondary hypothesis is that the median PFS with nab-paclitaxel and nivolumab will be significantly longer than the historical control (median PFS 3.6 months). ”

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Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC

Conditions: Squamous Cell Carcinoma of Head and Neck

Head and neck cancer squamous cell carcinoma (HNSCC) is a disease with poor survival, especially for African Americans, despite intense treatment including surgery, radiation, and chemotherapy. Delays between surgery and the start of postoperative radiation therapy (PORT) are common, cause excess mortality, and contribute to worse survival in African Americans. Our research team has developed NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based patient navigation (PN) intervention to decrease delays and racial disparities starting PORT. In this single-site, open label, parallel-group, randomized controlled trial of adults with surgically-managed, locally advanced HNSCC, will be randomized to NDURE versus usual care to assess the preliminary clinical impact of NDURE on delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the rate of PORT delay, racial disparities in the rate of PORT delay, and completion rate of key cancer care processes. Participants will also complete validated questionnaires at baseline and post-intervention to understand the theoretical constructs underlying NDURE . Post-intervention, patients and providers will undergo interviews to obtain in-depth understanding of the content, format, timing, and delivery of NDURE to optimize the intervention in preparation for a future multi-site study. NDURE could provide the first effective intervention to improve the delivery of timely, equitable PORT after HNC surgery, thereby improving survival for patients with HNC, decreasing racial disparities in mortality, and developing new standards of clinical care.

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NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma

This phase II trial investigates the effect of NBTXR3, radiation therapy, and pembrolizumab in treating patients with head and neck squamous cancer that has come back (recurrent) or has spread to other places in the body (metastatic). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. And hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, and pembrolizumab may kill more tumor cells.

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Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca

Conditions: Head and Neck Squamous Cell Carcinoma

The primary objective of this study is to assess safety and feasibility of pre-operative nivolumab in combination with either cabiralizumab, anti colony stimulating factor 1 receptor (CSF1R) or BMS-986253 (anti-interleukin-8) in patients with squamous cell carcinoma of head and neck (SCCHN) who will undergo surgery.

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Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of H&N

Conditions: Basal Cell Carcinoma of the Head and Neck

“The purpose of this study is to evaluate anti-PD-1 Neoadjuvant therapy in Basal cell carcinoma to provide a better outcome when administered prior to surgery and provide a therapeutic strategy to avoid surgery altogether. The study team will gather information about how Basal cell carcinoma responds to Pembrolizumab prior to surgery and to gather information about recurrence rates.

Pembrolizumab, is an investigational (experimental) drug that may improve the response of the immune system against cancer. Pembrolizumab is a manufactured antibody, much like the antibodies usually made by the human body to fight off infection. The idea behind developing this experimental drug is to stimulate the body’s immune system to kill cancer cells. Pembrolizumab antibody has been specifically made to block a program cell death-1 (PD-1) protein receptor, which is found on cells of the immune system. PD-1 receptor seems to slow down the immune response. Blocking PD-1 with pembrolizumab antibody may make the immune response more active and may improve the response of the immune system against cancer. Pembrolizumab is currently FDA approved for use in other malignancies. It has been used to treat a number of other diseases such as certain types of lung cancer, cervical cancer and lymphoma. The use of Pembrolizumab in this study is experimental because it is not approved by the Food and Drug Administration (FDA) for use in the treatment of Basal cell carcinoma.”

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Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck

Conditions: Lip, Oral Cavity Squamous Cell Carcinoma, Pharynx, Larynx, Squamous Cell Carcinoma

This phase II trial studies how well nivolumab works, with or without BMS986205, in treating patients with stage II-IV squamous cell cancer of the head and neck. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. BMS986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab with BMS986205 may work better than nivolumab alone in treating patients with squamous cell cancer of the head and neck.

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NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Resectable Oropharyngeal Squamous Cell Carcinoma

This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back (recurrent) who are undergoing surgery. NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells. The body produces T-cells which play an important role in body’s immune response and its ability to recognize tumor cells. This immunotherapy drug may boost body’s T-cells to help fight cancer and enhance body’s response to cancer.

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Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma

In this study, patients with recurrent or metastatic head and neck squamous cell carcinoma will receive first line treatment with olaparib, pembrolizumab, and carboplatin. The primary hypothesis is that olaparib, pembrolizumab and carboplatin will result in an overall response rate (ORR) higher than the historical ORR observed with pembrolizumab, platinum and 5-FU.

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Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

Conditions: Squamous Cell Carcinoma

The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.

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Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT)

Conditions: Head and Neck Cancer

The investigators propose evaluating the feasibility of using the novel cone beam computed tomography (CBCT)-guided Ethos system to deliver expedited, adaptive Quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers. Quad shot radiation was selected as the palliative regimen of choice given its low toxicity profile, well published efficacy in palliation, frequent usage in the US for palliation of head and neck cancers, and safety in the setting of re-irradiation. The use of the Ethos platform to perform online adaptive radiation planning and delivery remains novel and untested. The Ethos system would be used to consolidate CT simulation, replanning, and treatment for Quad shot patients receiving treatment with the benefit of reduced patient travel and a reduction in the unwanted delay between Quad shot cycles. The goal of this pilot study will be to evaluate the feasibility of the Ethos system to eliminate the need for a CT simulation for cycles 2 and 3 of Quad shot radiation.

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Pea Protein Oral Nutrition Supplement for the Reduction of Gastrostomy Tube Placement Rate in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiation Therapy

Conditions: Locally Advanced Head and Neck Carcinoma

This phase II trial studies the effect of a plant-based oral nutrition supplement, Kate Farms Standard 1.4 and/or Standard 1.0. as a primary source of nutrition in reducing the gastrostomy tube placement rate in patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and who are undergoing chemoradiation therapy. Gastrostomy tube (G-tube) placement can be used for enteral feedings and may lead to long term side effects such as swallowing dysfunction and lead to higher rates of permanent G-tube dependence. The Kate Farms pea protein oral nutrition supplement is formulated with organic, planted-based protein for easier digestibility without artificial sweeteners or additives and without common allergens such as dairy, soy, gluten or corn. It is nutritionally complete, calorie and protein dense and available in multiple flavors that can be consumed directly or as a base for other recipes. Giving pea protein oral nutrition supplement may provide nutritional support to decrease the need for therapeutic G-tube rate during chemoradiation compared to standard supportive care.

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Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer

Conditions: Metastatic Head and Neck Carcinoma, Paranasal Sinus Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7, Unresectable Head and Neck Squamous Cell Carcinoma

This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and cabozantinib may improve the chances of tumor response in patients with head and neck squamous cell cancer.

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Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

Conditions: Mucosal Melanoma of the Head and Neck

This is an open-label, single center, one cohort, non-randomized, phase I/II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.

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Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

Conditions: HNSCC,Lip SCC, Oral Cavity Cancer, Oropharynx Cancer, Larynx Cancer, Hypopharynx Cancer, Nasopharynx Cancer, Sinonasal Carcinoma, Cutaneous Squamous Cell Carcinoma, Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm (Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25 in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive Cancer Center, University of Michigan Comprehensive Cancer Center, and University of Washington Siteman Cancer Center.

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Pembrolizumab in Combination With Anti-platelet Therapy for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Conditions: Head and Neck Cancer

The purpose of this study is to see if anti-platelet therapy combined with anti-PD-1 immunotherapy can cause a more favorable immunologic response than with immunotherapy alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

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Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

Conditions: Thyroid Gland Anaplastic Carcinoma, Thyroid Gland Squamous Cell Carcinoma

This phase II trial studies the effect of pembrolizumab, dabrafenib, and trametinib before surgery in treating patients with BRAF V600E-mutated anaplastic thyroid cancer. BRAF V600E is a specific mutation (change) in the BRAF gene, which makes a protein that is involved in sending signals in cells and in cell growth. It may increase the growth and spread of tumor cells. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab, dabrafenib, and trametinib may help to control BRAF V600E-mutated anaplastic thyroid cancer when given before surgery.

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Pepinemab in Combination With Pembrolizumab in Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Conditions: Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)

The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab and determine a recommended Phase 2 dose (RP2D) in patients with advanced, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

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Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy

Conditions: Squamous Cell Carcinoma of the Head and Neck

In this Phase II trial of personalized immunotherapy in R/M HNSCC, gene expression of LAG3 and CTLA4 by RNA seq will be determined to select the appropriate agent (Ipilimumab or Relatlimab) to add to Nivolumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who have failed prior immunotherapy with anti-PD-1 or PD-L1 mAb therapy. The agent, either Ipilimumab or Relatlimab will be chosen based on the highest relevant immune gene expression (CTLA4 or LAG-3) as long as the minimum difference required is met.

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Ph1 Study of SL-172154 Administered Intratumorally in Subjects With Squamous Cell Carcinoma of the Head and Neck or Skin

Conditions: Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck

This is a Phase 1 open-label, multi-center, dose-escalation study to evaluate the safety, PK, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered by intratumoral injection in subjects with cutaneous squamous cell carcinoma (CSCC) or squamous cell carcinoma of the head and neck (SCCHN).

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Phase 2 Study of OBP-301 (Telomelysinâ„¢) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease

Conditions: Head and Neck Squamous Cell Carcinoma With Inoperable Recurrent or Progressive Disease

The purpose of this study is to test the effects, of the research study drug Telomelysin (OBP-301) in combination with pembrolizumab in subjects with inoperable, recurrent, or progressive squamous cell carcinoma of the head and neck. Telomelysin is an investigational treatment, while pembrolizumab and SBRT are approved standard treatments. The combination of these three treatments is also considered investigational.

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Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC

Conditions: Cancer of the Head and Neck

This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.

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Phase II Pantiumumab-IRDye800 in Head & Neck Cancer

Conditions: Head and Neck Cancer

The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.

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Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer

Conditions: Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma, Laryngeal Neoplasm, Radiation Therapy Recipient

This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.

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Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

Conditions: Recurrent Head and Neck Carcinoma, Locally Advanced Head and Neck Carcinoma

This phase I/II trial studies the side effects of interstitial photodynamic therapy and to see how well it works with standard of care chemotherapy in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor. It is not yet known how well porfimer sodium interstitial photodynamic therapy works, with or without standard of care chemotherapy, in treating patients with head and neck cancer.

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Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN

Conditions: Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Cancer Metastatic

Nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).

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Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

Conditions: Head and Neck Cancer

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

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Priming Immunotherapy in Advanced Disease With Radiation

Conditions: Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck

This study proposes to treat metastatic non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC) patients who are already initiating an immune checkpoint inhibitor (such as Nivolumab, Atezolizumab or Pembrolizumab) for disease treatment as per FDA approved guidelines. In these patients we will deliver a short-course radiation to a single systemic (non-CNS) site within 14 days of receiving the first dose of immune checkpoint inhibitors. This sequence allows radiation to release tumor antigens from immune inaccessible areas such as necrotic tumor or low perfusion to provide a robust anti-tumor immune response with immune checkpoint inhibitors.

The primary objective is to assess six-month progression free survival (PFS) compared to historical control.

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PROGRESS Trial – Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing

Conditions: Oropharyngeal Cancer, HPV-Related Squamous Cell Carcinoma

“Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).


The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. Rates of gabapentin-related side effects and discontinuation will also be investigated.”

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Proton Re-Irradiation for Recurrent Head and Neck Cancer

Conditions: Head and Neck Cancer

The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.

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Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition

Conditions: Advanced Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck, Locally Advanced Head and Neck Squamous Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

This is a single-arm, non-randomized pilot study to evaluate the efficacy and tolerability of combination quad-shot palliative radiotherapy with immunotherapy for advanced/recurrent/metastatic head and neck cancer.

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Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

Conditions: Head and Neck Neoplasms

The researchers hope that based on the study findings future patients may benefit from a more precise radiation treatment plan that can be developed more quickly and thus decrease the time from Computerized Tomography Simulation to start of treatment.

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Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

Conditions: Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant, Lip and Oral Cavity Squamous Cell Carcinoma,p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8,Stage III Laryngeal Cancer AJCC v8,Stage III Lip and Oral Cavity Cancer AJCC v8,Stage III Oral Cavity Verrucous Carcinoma, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8,Stage IVA Hypopharyngeal Carcinoma AJCC v8,Stage IVA Laryngeal Cancer AJCC v8,Stage IVA Lip and Oral Cavity Cancer AJCC v8,Stage IVA Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8

This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

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Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Conditions: Papillary Thyroid Cancer

“Traditionally, surgery has been the standard recommendation for treating papillary thyroid cancer. The risk of surgery including permanent hoarseness, permanent hypocalcemia, a mid-cervical scar, and the potential for permanent hypothyroidism may be unacceptable for some patients, especially with low risk papillary thyroid carcinoma. The recent American Thyroid Association guidelines have proposed the option of active surveillance with low risk papillary thyroid cancer less than 210 mm. However, most patients find observation anxiety provoking knowing of having cancer. Radiofrequency ablation (RFA) of small low risk papillary thyroid cancer is a promising therapeutic modality for these patients that reduces the risks associated with surgery and the anxiety of taking a watchful approach. However, this technique has not been validated in the North American population.

The investigators aim to describe the investigators’ initial experience with RFA of low risk papillary thyroid microcarcinoma (PTMC) compared to active surveillance (AS) done by Head and Neck Endocrine surgeons at Johns Hopkins Medical Institute.

Primary objective:

To evaluate the safety, efficacy and oncological outcomes of the procedure.

Secondary objective:

To determine the patient functional outcomes in comparison to the observational control.”

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Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC

Conditions: Squamous Cell Carcinoma of Head and Neck

To determine the outcomes of patients with specific head and neck cancer after undergoing radiation therapy with atezolizumab followed by surgery then radiation with or without chemotherapy according to national guidelines.

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Re-irradiation With NBTXR3 in Combination With Pembrolizumab for the Treatment of Inoperable Locoregional Recurrent Head and Neck Squamous Cell Cancer

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Unresectable Head and Neck Squamous Cell Carcinoma

This phase II trial studies the effect of re-irradiation with NBTXR3 in combination with pembrolizumab in treating patients with head and neck squamous cell cancer that cannot be removed by surgery (inoperable) and has come back (recurrent). NBTXR3 is a drug that is designed to improve the effectiveness (how well something works) of radiation therapy. The drug is injected into a tumor and activated (turned on) by radiation. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Radiation therapy, such as intensity modulated radiation therapy or intensity modulated proton therapy, uses high energy to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3 activated by radiation together with pembrolizumab may help to control head and neck squamous cell cancer.

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Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck

Conditions: Recurrent Head and Neck Cancer, Carcinoma, Squamous Cell of Head and Neck

Eligible participants with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck will be treated with reirradiation combined with anti-PD-1 mAb MK-3475 (generic name: pembrolizumab, trade name Keytruda®).

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Ruxolitinib in Operable Head and Neck Cancer

Conditions: Head and Neck Squamous Cell Carcinoma

The purpose of this study is to assess the safety and efficacy of ruxolitinib in patients with operable Head and neck squamous cell carcinoma (HNSCC) who are planned for definitive surgery.

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Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia

Conditions: Leukoplakia, Oral

This research study is studying an immunotherapy drug, as a possible treatment for oral proliferative verrucous leukoplakia (OPVL).

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Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer

Conditions: Recurrent Head and Neck Cancer

“Primary Objective: The primary objective of the study is to evaluate the safety of repeat administration of a dose level of Ad/PNP plus fludarabine phosphate (F-araAMP) which demonstrated anti-tumor activity in patients with advanced, locoregional head/neck cancer in a completed phase I study.

Secondary Objective: The secondary objective is to evaluate the antitumor activity of repeat administration of Ad/PNP plus F-araAMP.”

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Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

Conditions: HRAS Gene Mutation, HNSCC

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study and includes 2 types of patients: (1) the historical record of first line therapy in subjects with HRAS mutant HNSCC participating in Cohort 1 in whom first line outcome data are available and (2) matched control HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

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Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary Hypofunction

Conditions: Squamous Cell Head and Neck Cancer, Radiation Induced Xerostomia, Salivary Hypofunction

“Background: Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can cause problems like infections and tooth decay. Researchers hope a new drug can help people with dry mouth caused by radiation.

Objectives: To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in people whose parotid glands have had radiation.

Eligibility: People at least 18 years of age with a history of radiation therapy for head and neck cancer.”

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SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).

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Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)

Conditions: Head and Neck Cancer, Oropharynx Cancer, Oropharyngeal Squamous Cell Carcinoma

This is a phase II, non-randomized, therapeutic trial with the primary objective to determine the efficacy of reduced contralateral (C/L) elective nodal treatment volumes in preventing C/L recurrences at 2 years in patients with p16 positive oropharyngeal squamous cell carcinoma undergoing definitive or adjuvant RT.

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Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer

Conditions: Malignant Thyroid Gland Neoplasm, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Anaplastic Carcinoma, Thyroid Gland Medullary Carcinoma, Thyroid Gland Papillary Carcinoma, Thyroid Gland Squamous Cell Carcinoma

This phase II trial studies the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations (changes in the genetic material [deoxyribonucleic acid (DNA)]). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib before surgery may help shrink the tumors and help control the disease.

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Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck

Conditions: Squamous Cell Carcinoma, Nonmelanoma Skin Cancer, Cutaneous Squamous Cell Carcinoma

The purpose of this study is to research if a type of biopsy known as sentinel lymph node biopsy (SLNB) can help in determining the rate of tumor deposits that are hard to detect and identify in node-negative cutaneous squamous cell carcinoma of the head or neck.

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Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

Conditions: Glottic Carcinoma

The goal of treatment with radiation therapy is to deliver as high of a dose as possible to the target (tumor), while minimizing the dose to the normal tissues where late-side effects can drastically affect patient quality of life.

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Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions: Recurrent, Head and Neck Cancer

Brief Summary: Compare the overall survival of patients with the addition of docetaxel to the overall survival of patients treated with SBRT and cetuximab alone. In addition, we will determine the difference in progression free survival (PFS), the rate of local recurrence (LR) and of distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS, LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment and then randomized to either the control arm (cetuximab and SBRT only) or the experimental arm (cetuximab, SBRT, and docetaxel).

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Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer

Conditions: Recurrent Head and Neck Carcinoma

This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.

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Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer

Conditions: Recurrent Head and Neck Carcinoma

This phase II trial studies how well stereotactic body radiation therapy with HyperArc software technology works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

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Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck

Conditions: Recurrent Head and Neck Carcinoma, Head and Neck Cancer Metastatic, Head or Neck Cancer

This research study seeks to gain new knowledge about the addition of a carefully targeted “boost” dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. The name of the study intervention involved in this study is stereotactic body radiotherapy, which is a way of delivering radiation in a more precisely targeted way and with a higher dose than conventional radiotherapy.

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Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Conditions: Head and Neck Cancer

The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.

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Study of Magrolimab Combination Therapy in Participants With Head and Neck Squamous Cell Carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

The study consists of Safety Run-in and Phase 2 Cohorts.


The primary objectives of the safety run-in cohorts of this study are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with pembrolizumab + 5-fluorouracil (5-FU) + platinum chemotherapy, and docetaxel in combination with magrolimab in participants with head and neck squamous cell carcinoma (HNSCC).


Phase 2 Cohorts 1: To evaluate the progression-free survival (PFS) with magrolimab in combination with pembrolizumab + 5-FU + platinum versus pembrolizumab + 5-FU + platinum as assessed by independent central review.


Phase 2 Cohorts 2 and 3: To evaluate the efficacy of magrolimab in combination with pembrolizumab and magrolimab in combination with docetaxel as determined by the investigator-assessed objective response rate (ORR).

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Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Conditions: Head and Neck Neoplasms

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

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Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer

Conditions: Head and Neck Cancer

Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

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Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

Conditions: Squamous Cell Carcinoma of Head and Neck

For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab.

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Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

The aim of this study is to potentiate adaptive immunity to enhance the anti-tumor activity of anti-PD1 antibody by the addition of anti-CTLA4 antibody or anti-LAG3 antibody (relatlimab) given in subjects with resectable locally advanced HNSCC prior to surgical resection.

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Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

Conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma, Head and Neck Cancer Stage III, Head and Neck Cancer Stage IV, Head and Neck Cancer Metastatic, Cancer, Cancer of Esophagus, Cancer, Metastatic, Cancer of Head and Neck, Cancer of Mouth, Cancer of Neck

This study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.

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Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases

Conditions: Head and Neck Melanoma

Current imaging devices usually detect cancer prior to surgery. However, these devices cannot be used during the surgical procedure to visualize lymph nodes with cancer (called “sentinel lymph nodes”). This is a Phase II study, containing a total of 67 patients with head and neck cancer. The purpose of this study is to test if imaging, with cRGDY-PEG-Cy5.5-C dots is useful for evaluating your type of cancer. This is currently not approved by the FDA. The researchers want to see if cRGDY-PEG-Cy5.5-C dots, can improve upon the usual scans. As a part of your standard of care, you will initially undergo imaging of your lymph nodes prior to your surgery. Prior to your surgery, you will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours later using a device to image the location of the dye. We have tested, for the first time in humans, a new, experimental dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node mapping. This particle, the size of a small protein, will be injected around sites of your tumor before or during your surgery to identify diseased nodes using a hand-held camera system. The dye-labeled particle can be viewed in tissues that may contain tumor. The particles will not treat your cancer and any images or information found during this study will not be used for your treatment. The information collected may be used to guide the design of future studies to detect and/or treat tumors.

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Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN

Conditions: Head and Neck Cancer

This research study is studying immunotherapy in combination with radiation therapy as a possible treatment for head & neck cancer that has worsened or spread to another organ or part of your body.

The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).

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Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

“The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer.

The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and pembrolizumab.”

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Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer

Conditions: Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Conditions: Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma, Advanced Oral Cavity Squamous Cell Carcinoma, Advanced Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.

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Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer

Conditions: Head and Neck Carcinoma of Unknown Primary, Head and Neck Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7, Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Sinonasal Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7, Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7

This phase I trial studies the side effects and best dose of berzosertib (M6620) when given together with cisplatin and radiation therapy in treating patients with head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes (locally advanced). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving M6620 together with cisplatin and radiation therapy may work better in treating patients with locally advanced head and neck squamous cell carcinoma.

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Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Added to Radiation or Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma

This phase II trial studies the effect of pembrolizumab in combination with radiation therapy or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin and carboplatin kill tumor cells by stopping them from dividing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab in combination with radiation therapy or pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

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The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC

Conditions: Head and Neck Cancer

The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

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Tissue and Hematopoietic Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer

Conditions: Malignant Melanoma, Head and Neck Cancer

The overall goal of this study is to develop a pre-clinical platform of melanoma and head and neck squamous cell cancer that will allow the investigators to learn more about these diseases and discover better and more individualized treatments.

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TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck

Conditions: Oropharyngeal Cancer, Squamous Cell Carcinoma, Human Papilloma Virus

This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.

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Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC

Conditions: HNSCC

To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.

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Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC

Conditions: Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck

This is an open-label, randomized, phase II trial to test the efficacy of Ibrutinib in combination with either Nivolumab or Cetuximab in the treatment of recurrent and/or metastatic head an neck squamous cell carcinoma

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Using MASL to Combat Oral Cancer

Conditions: Squamous Cell Carcinoma of Head and Neck

This project will evaluate the expression of a receptor called podoplanin (PDPN) in cells from oral cancers and precancerous lesions. We will also determine how sensitive oral cancer cells are to a potential drug called Maackia amurensis seed lectin (MASL

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Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

Conditions: Head and Neck Cancer

Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.

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Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

Conditions: Cancer Neck, Larynx Cancer, Glottis Tumor

This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN). Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.

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VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating participants with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

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Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies

Conditions: Throat Carcinoma

This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.

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Window Trial 5-aza in HNSCC, T-tare

Conditions: Head and Neck Squamous Cell Carcinoma

The purpose of this study is to assess the activity of 5-azacitidine in patients with Human Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck cancers or head and neck cancer cells cultured in laboratories suggest that treatment with 5-azacitidine increases changes in cancer cells that lead to their death. This study is designed to determine if similar changes occur in cancer cells of patients with head and neck cancer.

The study also aims to determine the amount of a specific type of protein, p53 before and after treatment. Research has shown that the p53 protein is associated with anti-tumor activity.

Finally, this study is measuring the amount of a specific type of protein called interferon in your tumor tissue. Interferons are proteins made and released by the body in response to pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons allow for communication between cells to trigger the protective defenses of the immune system that remove pathogens (disease causing agents) or tumors.

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HPV Postive Head and Neck Cancer Focused Trials

Image for Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

HNCA advises all patients to discuss available Clinical Trials with their medical team.

See if you qualify!


A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

Conditions: Squamous Cell Carcinoma of the Oropharynx, HPV16 Positive

This study will assess the ability of ISA101b to improve Overall Response Rate in subjects with HPV16 positive OPC, when combined with cemiplimab, an investigational anti-PD-1 antibody being developed by Regeneron Pharmaceuticals. ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16. Trials in HPV16 driven malignancies indicate it has activity in HPV16 driven malignancies including oropharyngeal and cervical cancers. Cemiplimab, also known as REGN2810, is in late stage trials and appears to have similar activity to approved anti PD-1 antibodies in a number of malignancies .

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A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Conditions: Squamous Cell Carcinoma of Head and Neck

The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

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A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

Conditions: Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer

“An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts.

Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.

Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1.”

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A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

Conditions: Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma

This is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

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A Phase 1/2 Study With HPV16 + Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma and Other HPV 16+ Cancers

Conditions: HPV-Related Squamous Cell Carcinoma

This is an First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.

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Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

Conditions: CDKN2A-p16 Positive, Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7

This phase II trial studies how well alpelisib works in treating participants with human papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by surgery. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

Conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Nasal Cavity and Paranasal Sinus Carcinoma, Oral Cavity Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Hypopharyngeal Carcinoma, Recurrent Laryngeal Carcinoma, Recurrent Nasal Cavity and Paranasal Sinus Carcinoma, Recurrent Oral Cavity Carcinoma, Recurrent Oropharyngeal Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVC Hypopharyngeal Carcinoma AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8

This phase II trial studies how well celecoxib works through surgery and radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced). Celecoxib is Food and Drug Administration approved to treat arthritis, acute pain, and painful menstrual periods. Adding celecoxib to standard of care treatment may help to decrease the amount of time between surgery and radiation therapy.

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Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Conditions: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Unknown Primary, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVC Hypopharyngeal Carcinoma AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Stage IVC Lip and Oral Cavity Cancer AJCC v8

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

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Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease

Conditions: Squamous Cell Carcinoma

The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. The researches will look at how the two approaches affect participants’ quality of life, health outcomes, and expenses (for example, costs of routine visits and procedures). They will also determine doctors’ and patients’ satisfaction with tele-surveillance.

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De-Escalation Therapy for Human Papillomavirus Negative Disease

Conditions: Human Papilloma Virus, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, HPV-Related Squamous Cell Carcinoma, HNSCC

This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject’s cancer.

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De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer

Conditions: Basaloid Squamous Cell Carcinoma, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Oropharyngeal Squamous Cell Carcinoma, Papillary Squamous Cell Carcinoma, Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Squamous Cell Carcinoma

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

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HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for “Intermediate Risk” HPV-16-associated Head and Neck Squamous Cell Carcinoma

Conditions: HPV-Related Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma

This clinical trial will evaluate a new combination of pembrolizumab, HPV-16 E6/E7 specific therapeutic vaccination (ISA101b) and cisplatin-based chemoradiotherapy for patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck squamous cell carcinoma.

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Improving Detection and Early Action for HPV-positive Oropharynx Cancer

Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma

This study aims to determine whether a blood test for HPV DNA can improve diagnosis of HPV-positive oropharynx cancer (HPV-OPC).

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Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma

Conditions: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Basaloid Carcinoma, Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Posterior Tongue Squamous Cell Carcinoma, Soft Palate Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Tonsillar Squamous Cell Carcinoma

This phase II trial studies the side effects and best dose of ipilimumab, nivolumab, and radiation therapy and how well they work in treating patients with advanced human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ipilimumab, nivolumab, and radiation therapy may work better in treating patients with HPV positive oropharyngeal squamous cell carcinoma.

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Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma

Conditions: HPV-Associated Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Neck

“The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation.


Accrual for Cohort A has been completed.


Cohort B is active and continues to enroll participants where surgery is optional and proton is allowed.”

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Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer

Conditions: Oropharyngeal Squamous Cell Carcinoma

Doctors leading this study will give blood tests to head and neck cancer participants during the beginning of chemotherapy treatment (also known as induction therapy) to see if these blood tests can help predict tumor shrinkage after therapy and reduce the amount of additional radiotherapy or chemotherapy treatment the participant may need. This study will also examine ways to reduce overall side effects of treatment using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone.

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Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma

Conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, KRAS Protein Variant, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy, cisplatin, and cetuximab may work better in treating patients with HPV positive, KRAS-variant oropharyngeal squamous cell carcinoma compared to radiation therapy and cisplatin alone.

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Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer

Conditions: Oropharynx Squamous Cell Carcinoma

The purpose of this study is to find out if the addition of nivolumab can improve 2 year progression free survival (PFS) as compared to standard of care of fractionated radiation therapy (RT) and carboplatin/paclitaxel in subjects with high risk HPV-related squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate). Fractionated means the radiation will be administered in fragments or parts across multiple days.

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Risk-adapted Therapy in Low-risk HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile – The ReACT Study

Conditions: HPV-Associated Oropharyngeal Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Stage, HPV-Related Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Pathologic Stage

“This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test.


The names of the test and treatments involved in this study are:


NavDx® HPV ctDNA testing (HPV blood test)

Radiation therapy

Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)”

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Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma

Conditions: Head and Neck Cancer

This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.

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Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration in HPV+ Head and Neck Cancer of Unknown Primaries

Conditions: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Carcinoma of Unknown Primary, Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

This early phase I trial evaluates the clinical outcome of mucosal sparing adjuvant radiotherapy after surgical exploration in HPV+ head and neck cancer of unknown primaries. The purpose of this research is to assess if radiation treatment to the neck only for tumors with unclear original locations after careful surgical evaluation will lead to historical rates of disease control while reducing side effects and toxicity from treatment.

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Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

Conditions: Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head and Neck

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

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Testing the Addition of an Anti-cancer Drug, BAY1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer

Conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVC Hypopharyngeal Carcinoma AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Stage IVC Lip and Oral Cavity Cancer AJCC v8, Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Unresectable Head and Neck Squamous Cell Carcinoma, Unresectable Hypopharyngeal Squamous Cell Carcinoma, Unresectable Laryngeal Squamous Cell Carcinoma, Unresectable Oral Cavity Squamous Cell Carcinoma, Unresectable Oropharyngeal Squamous Cell Carcinoma

This phase I trial evaluates the best dose, possible benefits and/or side effects of combination therapy with BAY1895344, stereotactic body radiation, and pembrolizumab in treating patients with head and neck squamous cell cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). BAY1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving BAY1895344, stereotactic body radiation therapy in combination with pembrolizumab may shrink or stabilize head and neck squamous cell cancer for longer than treatment with radiation and immunotherapy without BAY1895344.

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The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) (SIRS TRIAL)

Conditions: Human Papilloma Virus, Oropharyngeal Squamous Cell Carcinoma

“In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. While the long-term consequences of chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients.


Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good prognosis features will then be followed without postoperative radiotherapy. Patients with subsequent recurrence will be treated with either surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is expected that over 50% of patients treated with surgery will have had a curative treatment and will avoid radiation therapy entirely and long-term survival will not be changed by withholding radiation therapy to good prognosis patients after surgery. There are exploratory biomarkers of risk of recurrence that will be collected and studied.


There are currently few trials examining the role of de-escalation using surgery alone in intermediate and early T-stage HPV related disease. New surgical techniques have broadened the range of patients capable of achieving a complete resection and the functional outcomes in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and radiotherapy raise the possibility that delayed or salvage treatment in early stage patients would be highly effective, would result in similar survival outcomes and radiotherapy could be applied to a much smaller population then current standards call for. Looked at from a different perspective, the need for post-operative radiotherapy in this younger, HPV+ and more functional population has not been validated in clinical trials to date.”

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Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma

Conditions: Oropharyngeal Squamous Cell Carcinoma

This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.

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Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer

Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma

This study will enroll patients with HPV-associated oropharyngeal cancer, undergoing resection of all gross visible disease at the primary site and in the lymph nodes. A total of 36 patients who have had or will require surgery to remove cancer cells prior to starting chemoradiation may be enrolled. All eligible patients will receive de-intensified cisplatin-based chemoradiation, with high-risk patients receiving a higher dose and longer treatment period than other patients on the study. The study will assess whether a de-intensified version of standard chemoradiation treatment will be just as effective in treating HPV-associated oropharyngeal cancer while causing less side effects than standard dosing.

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Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Conditions: Malignant Neoplasms of Lip Oral Cavity and Pharynx, Oropharyngeal Cancer

“The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer.


This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational.


Up to 75 participants will be enrolled in this study. All will take part at MD Anderson.”

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Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Cancer Stage IV, Head and Neck Cancer Stage III, HPV-Related Carcinoma, HPV-Related Malignancy, HPV-Related Squamous Cell Carcinoma

“The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer.


Patients will be treated with 3 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.”

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Side Effects and Head and Neck Cancer

Image for MeriaGTx radiation-induced xerostomia clinical trial

HNCA advises all patients to discuss available Clinical Trials with their medical team.

See if you qualify!


Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.

Conditions: Chemoradiotherapy-Induced Severe Oral Mucositis

This study is being performed to evaluate the effectiveness of a new drug, clonidine HCl MBT, to prevent the onset of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) who are being treated with chemoradiotherapy. OPC occurs on the back of the tongue or throat and is often treated by the use of chemoradiotherapy, where radiation is localized to these areas. Radiation to the OPC affected tissues causes the release of small proteins called cytokines that cause damage to the area surrounding the tumor including the oral cavity. This damage is characterized by the formation of mucositis which includes redness, pain and ulcers in the mouth and back of the throat. In addition, as more chemoradiation is administered to treat OPC, the inability to eat a solid diet (a Grade 3 mucositis) or to consume anything at all by mouth (a Grade 4 mucositis) occurs in many patients. Collectively, Grade 3 and Grade 4 mucositis is referred to as SOM. It is a frequent, debilitating side effect of chemoradiation in OPC that may cause patients to stop or interrupt their treatment, develop other side effects like the inability to swallow, or require the increased use of pain medications. OPC survivors who have successful treatment of their tumors often develop permanent swallowing, speaking and range of motion issues that may be linked back to the inability to eat and/or drink caused by SOM during their chemoradiotherapy treatment. Clonidine may inhibit the production of cytokines that cause SOM and clonidine HCl mucoadhesive buccal tablet (MBT) has been designed to deliver sustained high levels of clonidine in the oral cavity, potentially decreasing cytokine production and leading to a decrease in the incidence of SOM. Clonidine HCl MBT is a once per day treatment provided as a tablet that a patient may self-administer to the gums, where it sticks tightly to release clonidine over many hours. The primary objective of this Phase 2b/3 study is to evaluate whether clonidine HCl MBT is more effective than placebo MBT in decreasing the incidence of SOM.

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High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors

Conditions: Cranial Nerve Disorder, Head and Neck Carcinoma, Oropharyngeal Carcinoma

This phase I/II trial studies the side effect and best dose of steroid therapy (prednisone or methylprednisolone) in improving symptoms of late radiation-associated lower cranial neuropathy in oropharyngeal cancer survivors. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.

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PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

Conditions: Dysphagia

“Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and at least half of HNC patients require feeding tubes during RT.


Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before a swallowing problem begins-PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs-RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective.


To address this gap, the primary aim of this international, multi-site 3-arm pragmatic randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our secondary aim proposes to compare the relative benefit or harm of these swallowing interventions on secondary outcomes considered relevant to our stakeholder partners.”

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Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Conditions: Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma

This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

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Low-Level Laser in Head and Neck Chronic Lymphedema

Conditions: Head and Neck Cancer, Lymphedema, Fibrosis

The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.

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Commensal Oral Microbiota in H&N Cancer

Conditions: Head and Neck Cancer, Oral Mucositis

The ARMOR Trial will test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. Participants will attend a screening/baseline visit, weekly intervention visits while they are undergoing RT or chemoRT, and a visit 3 months after completing RT or chemoRT. At intervention visits, samples will be collected (such as saliva, oral swabs) and participants will receive their assigned study intervention, either Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP), which includes a dental cleaning and treatment to the oral mucosa, or a Standard of Care Oral Hygiene, which includes teeth brushing and no treatment to the oral mucosa.

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Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Conditions: Head and Neck Cancer, Radiation Dermatitis

“This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck.


Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.”

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EMST and Swallowing in Long-Term Survivors of HNCA

Conditions: Head and Neck Neoplasms, Deglutition Disorders

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.

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EMST in Patients Undergoing CRT for HNCA

Conditions: Head and Neck Neoplasms, Deglutition Disorders

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT/CRT).

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Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest

Conditions: Head and Neck Neoplasms, Dysesthesia

The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.

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MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

Conditions: Head and Neck Squamous Cell Carcinoma, Oral Mucositis

The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).

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A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema

Conditions: Lymphedema, Lymphedema of Face, Lymphedema, Secondary, Lymphedema Due to Radiation, Lymphedema; Surgical

To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.

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MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Conditions: Mucositis Oral, Head and Neck Cancer

This study will examine if the administration of prophylactic MucoLox formulation versus sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ± chemotherapy will result in significantly fewer subjects experiencing severe mucositis.

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Treatment of Radiation and Cisplatin Induced Toxicities With Tempol

Conditions: Mucositis, Nephrotoxicity, Ototoxicity

A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.

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Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado

Conditions: Obstructive Sleep Apnea, Squamous Cell Carcinoma of Head and Neck

Obstructive sleep apnea (OSA) is increasingly recognized in patients with squamous cell carcinoma of the head and neck (SCCHN). The prevalence prior and after cancer therapy is not well understood. OSA is identified as a contributing factor for daytime somnolence and quality of life (QOL), yet treatment of OSA in the SCCHN population has not been studied. The investigators hope to identify the disease course of sleep apnea, risk factors for development, and impact on QOL with treatment of OSA in a population of patients with SCCHN.

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Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

Conditions: Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Head and Neck Cancer

The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce the incidence of severe oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving concurrent radiation and chemotherapy.

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Endodontic-Restorative Pre-Radiation Therapy of Head and Neck Cancer Patients

Conditions: Pulpitis – Irreversible, Caries, Head and Neck Cancer

Pilot study involving 20 patients undergoing dental treatment prior to radiation therapy. Comparison of outcome parameters to existing data of age and gender matched patients.

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Blinded Dry Mouth Spray Crossover Study

Conditions: Xerostomia, Head and Neck Cancer, Xerostomia Following Radiotherapy

“To identify the effectiveness of two mouth sprays at relieving symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.


To assess patient quality of life and mouth acidity following use of two mouth sprays meant to relieve symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.”

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A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia

Conditions: Radiation-Induced Parotid Gland Hypofunction, Xerostomia Due to Radiotherapy, Head and Neck Cancer

“Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen’s duct to a single parotid gland in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one targeted parotid gland:


To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.

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Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

Conditions: Head and Neck Squamous Cell Carcinoma

This is a single-arm prospective clinical trial to determine the safety and feasibility of using transdermal buprenorphine in alleviation of radiation induced mucositis pain in head and neck cancer patients.

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Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

Conditions: Head and Neck Carcinoma

This phase II trial compares different pain management interventions (standard of care [SOC], neurofeedback [NFB] training, and compassionate high alert team [CHAT]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.

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Pain Management for Head and Neck Cancer Survivors

Conditions: Head and Neck Carcinoma

This clinical trial improves an existing pain management program and tests its effect on head and neck cancer survivors. This trial aims to find a better program to improve pain-related physical functioning, mood, and quality of life in a sample of individuals who have undergone treatment for head and neck cancer.

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Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer

Conditions: Head and Neck Cancer, Dysphagia

Veterans following treatment of head and neck cancer can be left with lasting swallowing impairment that may require diet alterations, need for feeding tubes, and risk of pneumonia. The investigators’ previous trial tested a new swallowing treatment approach to target respiratory-swallow coordination. The results revealed improvements in respiratory-swallow coordination and swallowing function. The goal of this study is to determine the impact and durability of respiratory-swallow training (RST) on clinical outcomes necessary for eating, drinking, health, and quality-of-life in Veterans with swallowing impairment following treatment for head and neck cancer. A total of 88 participants will be recruited and randomly assigned to the RST or standard of care. An additional 11 participants will be recruited to RST plus a home practice portion to obtain preliminary data regarding efficacy of home practice.

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Studies Including Head and Neck Cancers and Other Conditions
5-aminolevulinic Acid In Advanced Malignancies

Conditions: Advanced Solid Tumor

This is a phase 1, open label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study to determine the maximum tolerated doses (MTD) or recommended phase 2 doses (RP2D) of both ALA and RT. Once the MTDs are identified, the cohort providing the highest dose intensity at or below the MTD (if supported by emerging PK and biomarker data) will be selected for an expansion phase for the purpose of refining the safety assessment and assessing preliminary efficacy. The initial dose escalation phase will enroll at least 20 patients across a variety of tumor types, after which concurrent disease site-specific expansion cohorts will accrue, each consisting of 20 patients. Anatomic site-specific cohorts will include patients with symptomatic metastatic disease to specific anatomic regions, where varying toxicity may be expected (Head and Neck, Thorax and Abdomen/Pelvis).

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A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors

Conditions: Advanced Solid Tumors, Metastatic Solid Tumors

This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.

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A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

Conditions: Advanced or Metastatic Solid Tumors

“To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors.
To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.”

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A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine

Conditions: Lung Cancer, Head and Neck Cancer

The purpose of this study is to further advancements in biospecimens (blood cellular free component, e.g., plasma, serum, tissue, urine), in order to develop precision medicine, for lung cancer management and lung cancer screening (synergy with imaging). A co-clinical trial approach, with integrative analyses leveraging data from the treatment of genetic mouse models of lung cancer along with clinical samples and data from lung cancer patients, will be used to elucidate genomic background metrics, identify cell free DNA mutations, and further refine the liquid biopsy approach. Blood and urine samples will be analyzed for different genetic components. The tissue biopsy will be implanted into a mouse and after the cancer grows in the mouse the cancer DNA from the mouse will be compared with the human blood.

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A First in Human, Dose Escalation Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors

Conditions: Non-small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Other Metastatic Solid Tumors

This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.

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A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Conditions: Metastatic Neoplasm

“Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options.
Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.

Secondary Objectives:

  • To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab.
  • To assess the immunogenicity of SAR441000.
  • To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab.
  • To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000.
  • To determine the recommended dose of SAR441000 for the expansion phase.”

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A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors

Conditions: Advanced Solid Tumor

“This is a first-in-human, Phase 1/2 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of CDK-002 in subjects with advanced/metastatic, recurrent, injectable solid tumors, whose disease has progressed despite receiving standard of care treatment. CDK 002 will be administered intratumorally (IT).

Part A will enroll subjects with advanced/metastatic, recurrent, injectable solid tumors with emphasis on head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC) and cutaneous squamous cell carcinoma (cSCC).”

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A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

Conditions: HER2 Positive Solid Tumors

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

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A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

Conditions: Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Breast Cancer, Other Solid Tumors

This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.

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A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Conditions: Neoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms, Sarcoma, Ovarian Neoplasms, Brain Neoplasms, Thyroid Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma, Salivary Gland Neoplasms, Head and Neck Neoplasms, Thyroid Cancer, Papillary, Lymphoma, Large-Cell, Anaplastic, Neoplasms by Site, Respiratory Tract Neoplasms, Thoracic Neoplasms, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Central Nervous System

This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.

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A Phase 1 Study With ABBV-CLS-484 in Subjects With Locally Advanced or Metastatic Tumors

Conditions: Advanced Solid Tumor Cancer

“The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent. The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).

Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.

Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent to eligible subjects who have advanced solid tumors.

Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting agent in subjects with locally advanced or metastatic, relapsed or refractory gastric or GEJ adenocarcinoma.”

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A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6 (IT-01)

Conditions: Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma, Pancreatic Cancer, Liver Cancer, Colon Cancer, Lung Cancer, Bile Duct Cancer, Chordoma of Sacrum, Sarcoma

This study evaluates the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study is being conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Sponsor also plans to test INT230-6 in combination with anti-PD-1 antibodies.

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A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

Conditions: Advanced Solid Tumor Cancer

“The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent. The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).

Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.

Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent to eligible subjects who have advanced solid tumors.

Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting agent in subjects with locally advanced or metastatic, relapsed or refractory gastric or GEJ adenocarcinoma.”

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A Phase 1/2 Study of CYT-0851, an Oral RAD51 Inhibitor, in B-Cell Malignancies and Advanced Solid Tumors

Conditions: Malignancy, Non-hodgkin Lymphoma, Multiple Myeloma, Breast Cancer, Ovarian Cancer, Soft Tissue Sarcoma, Head and Neck Cancer, DLBCL, Mantle Cell Lymphoma, Follicular Lymphoma, Pancreatic Cancer, CLL, Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer

This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of the oral RAD51 inhibitor CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose as a monotherapy and in combination with chemotherapy for evaluation in these patients.

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A Phase 1b Dose Escalation/Expansion Study of Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies

Conditions: Stage III Cutaneous Melanoma, Stage IV Cutaneous Melanoma, Locally Advanced Melanoma, Locally Advanced Solid Neoplasm, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Urothelial Carcinoma, Non-Small Cell Lung Carcinoma, Stage IB Lung Cancer AJCC v7, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ureter Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ureter Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

This phase I trial studies the best dose and side effects of abexinostat and how well it works with given together with pembrolizumab in treating participants with microsatellite instability (MSI) solid tumors that have spread to other places in the body. Abexinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving abexinostat and pembrolizumab may work better in treating participants with solid tumors.

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A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies

Conditions: Breast Cancer, Colorectal Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer, Acral Lentiginous Melanoma, Head and Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma, Urothelial Carcinoma, DMMR Colorectal Cancer, MSI-H Colorectal Cancer, Melanoma, Platinum-Resistant Primary Peritoneal Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Epithelial Ovarian Cancer

ATRC-101-A01 is a Phase 1b, open-label dose escalation trial of ATRC-101, an engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally occurring human antibody. The safety, tolerability, PK, and biological activity of ATRC-101 will be characterized when administered every two weeks (Q2W) or every 3 weeks (Q3W) as a monotherapy or in combination with other anticancer agents.

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A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

Conditions: NSCLC, Non Small Cell Lung Cancer, RCC, Renal Cell Cancer, Pancreatic Cancer, Urothelial Cancer, Head and Neck Cancer, DLBCL, Diffused Large B Cell Lymphoma, MSS, Microsatellite Stable Colon Cancer, TNBC, Triple Negative Breast Cancer, Melanoma

The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

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A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

Conditions: Advanced or Metastatic Solid Tumors, Non-Small Cell Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma

This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors.

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A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer

Conditions: Non-small Cell Lung Cancer, Gastric Carcinoma, Gastroesophageal Junction Carcinoma, Classical Hodgkin Lymphoma, Diffuse Large B-cell Lymphoma, Peripheral T-cell Lymphoma, Cutaneous Melanoma, Head and Neck Squamous Cell Carcinoma, Bladder Cancer, Ovarian Cancer, Triple Negative Breast Cancer, Cervical Cancer

“This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas.

The study will have three parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors.

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A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With BI 754091 to Patients With Advanced Solid Tumors Having the B7-H6 Marker

Conditions: Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Head and Neck Neoplasms, Gastrointestinal Neoplasms

“This study is open to adults with advanced solid tumors whose previous cancer treatment was not successful. People can participate if their tumor has the B7-H6 marker or if they have colorectal cancer.

The study tests 2 medicines called BI 765049 and BI 754091. Both medicines may help the immune system fight cancer.

The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with BI 754091 the participants can tolerate. In this study, BI 765049 is given to people for the first time.

Participants can stay in the study for up to 3 years, if they benefit from treatment and can tolerate it. During this time, they get BI 765049 alone or in combination with BI 754091 as infusion into a vein every 3 weeks.

The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or BI 754091. The doctors also regularly monitor the size of the tumor.”

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A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

Conditions: Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor, Thoracic Cancer, Gynecologic Cancer, Gynecologic Tumor, Melanoma

The purpose of this study is to find out whether the Integrative Medicine at Home (IM@Home) program can help reduce patients’ symptoms (such as tiredness, pain, or insomnia) and improve their satisfaction with treatment for their disease. The IM@Home program offers virtual (online rather than in-person) group classes focusing on mind-body practice. Mind-body practice is a health practice that combines mental focus, controlled breathing, and body movements to help relax the body and mind.

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A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer

Conditions: HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer

This Window Of Opportunity clinical trial will examine the immunologic effects of the study agent HB-201 in the head and neck or cervical cancer, when administered either by IT injection or by IV route.

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A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

Conditions: Melanoma, Non-Small Cell Lung Cancer, Bladder Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Renal Cancer, Head and Neck Cancer, Other Solid Cancers

This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of RO7198457 as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).

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A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Conditions: Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

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A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

Conditions: Melanoma, Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma, Ovarian Cancer, Cholangiocarcinoma, Bladder Urothelial Carcinoma, Pancreatic Adenocarcinoma, Colorectal Cancer, Esophageal Cancer, Hepatic Cancer, Head and Neck Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Other Solid Tumors, Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma, Indolent B-cell Lymphomas, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Waldenstrom’s Disease, Marginal Zone Lymphoma, Mucosa Associated Lymphoid Tissue, Small Lymphocytic Leukemia

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140, either alone or in combination with CDX-301, and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

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A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.

Conditions: Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Solid Tumor

This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).

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A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Conditions: Small Cell Lung Cancer, Non-small Cell Lung Cancer, Squamous, Non-small Cell Lung Cancer, Non-squamous, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Prostate Cancer, Melanoma

This trial will study ladiratuzumab vedotin (LV) to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.

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A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

Conditions: Pancreatic Cancer, BRAF Mutant Colorectal Cancer, Melanoma, Triple Negative Breast Cancer, Head and Neck Squamous Cell Cancer, Cervical Squamous Cell Cancer, Esophageal Squamous Cell Cancer, Lung Squamous Cell Cancer

The primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies that have progressed despite standard therapy or for which no effective standard therapy exists

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A Study of LOXO-292 in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer

Conditions: Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

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A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With a PD-1 Inhibitor

Conditions: Cancer, Tumor, Solid, Malignant Neoplasm, Metastatic Cancer, Advanced Solid Tumor, Non Small Cell Lung Cancer, TNBC – Triple-Negative Breast Cancer, Melanoma, Head and Neck Squamous Cell Carcinoma

This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with a PD-1 inhibitor in subjects with advanced solid tumors.

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A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions: RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Disease, Carcinoma, Bronchogenic, Bronchial Diseases, Head and Neck Neoplasms, Adenocarcinoma, Carcinoma, Neoplasms by Histologic Type, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.

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A Study of PRT1419 in Patients With Advanced Solid Tumors

Conditions: Sarcoma, Melanoma, Lung Cancer, Breast Cancer, Esophageal Cancer, Cervical Cancer, Head and Neck Cancer

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.

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A Study of SGN-B6A in Advanced Solid Tumors

Conditions: Carcinoma, Non-small Cell Lung, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Esophageal Squamous Cell Carcinoma, Ovarian Neoplasms, Cutaneous Squamous Cell Cancer, Exocrine Pancreatic Adenocarcinoma, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms

“This trial will look at a drug called SGN-B6A to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors.”

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A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Conditions: Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck

“In this study, people with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are getting side effects from these combined treatments and how much TAK-676 people with these cancers can receive without getting side effects from it.

Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle.”

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A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

Conditions: Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma, Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Cholangiocarcinoma, Bladder Urothelial Carcinoma, MSI-H Colorectal Cancer, Esophageal Cancer, Hepatic Cancer, Head and Neck Cancer, Other Solid Tumors

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

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A Study of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)

Conditions: Neoplasm Metastasis

The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive V937 in Combination with Pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of V937 administered in combination with pembrolizumab.

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A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Conditions: Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Colorectal Carcinoma, Non-small Cell Lung Carcinoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Endometrial Carcinoma, Mesothelioma, Neuroendocrine Carcinoma, Cervical Cancer, Small Cell Lung Carcinoma, Squamous Cell Carcinoma of the Anus, Castration-Resistant Prostate Carcinoma, Nasopharyngeal Carcinoma, Cholangiocarcinoma, Basal Cell Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma, Thymoma, Thymic Carcinoma, Squamous Cell Carcinoma of the Penis, Vulvar Carcinoma, Solid Tumors With Published Evidence of Anti-tumor Activity With Anti-PD1/PDL1 and/or Anti-CTLA4-directed Therapy, Malignant Adnexal Neoplasms, Non-squamous Cell Salivary Gland Carcinoma

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

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A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

Conditions: Melanoma, Cervical Carcinoma, Pancreatic Carcinoma, Triple Negative Breast Cancer, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Carcinoma, Small Cell Lung Carcinoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Advanced or Metastatic Solid Tumors, Prostate Carcinoma, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Intrahepatic Cholangiocarcinoma, Squamous Cell Anal Cancer, Squamous Cell Penile Carcinoma, Squamous Cell Vulvar Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma

This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.

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A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

Conditions: Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Renal Cell Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma, Non-small Cell Lung Carcinoma, Small Cell Lung Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma, Advanced Solid Tumors, Undifferentiated Pleomorphic Sarcoma

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.

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A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Conditions: Advanced Solid Tumors Cancer

The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

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A Study to Evaluate Enfortumab Vedotin in Subjects With Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Conditions: Locally Advanced or Metastatic Malignant Solid Tumors

“The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR).

This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin.”

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A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer

Conditions: Carcinoma, Squamous Cell

This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.

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A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults

Conditions: Advanced Solid Tumors

“Researchers are looking for a better way to treat advanced solid cancers including head and neck cancer, lung cancer and bladder cancer.

In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumor cells. The study drug, BAY 2416964, is a small molecule which blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY 2416964 given together with a cancer treatment called pembrolizumab may help shrink tumors in people with cancer.

The main aims of this study are to find for BAY 2416964 in combination with pembrolizumab,

how safe this drug combination is
how it affects the body (also referred to as tolerability)
the highest amount of BAY 2416964 that can be given in combination with pembrolizumab without too many side effects.
The researchers will also study the action of BAY 2416964 in combination with pembrolizumab against the cancer.

The participants in this study will get BAY 2416964 and pembrolizumab. BAY 2416964 will be given in tablet form by mouth. Pembrolizumab will be given as an intravenous (IV) infusion. An IV infusion is given through a needle into a vein.

This study will have two parts. The first part will help find the most appropriate dose that can be given in the second part.

Each participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY 2416964. The amount of BAY 2416964 that is given increases step-wise from one group to the next. The dose of pembrolizumab will always be the same.

The participants of the second, so called dose expansion part, will receive the most appropriate dose of BAY 2416964 found in the first part.

During the study, the participants will receive the treatment in 3-week periods called cycles. In each cycle, the participants will in general get pembrolizumab once and BAY 2416964 in a daily schedule. These 3-week cycles will be repeated throughout the trial. The participants can take the study treatment until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 4 visits in each cycle. Some of the visits can also be done via phone.

During the study, the study doctors and their team will:

take blood and urine samples
check if the participants’ cancer has spread using computed tomography scans or magnetic resonance imaging scans of the participants’ tumors
check the participants’ overall health
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.”

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A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors

Conditions: Solid Tumors

“Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.

The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).

The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.

During the trial, the doctors will take pictures of the participants’ tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants’ heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.”

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ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

Conditions: Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer

ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.

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Assessing the Immunogenicity of pING-hHER3FL

Conditions: Advanced Cancer

“This study is a phase I clinical trial will that will use an investigational cancer vaccine called pING-hHER3FL. pING-hHER3FL is a circular piece of DNA that produces the full length human HER3 protein and will be used in a phase I study as immunotherapeutic agent to target cancers that are known to express the human epidermal growth factor receptor HER3. The human epidermal growth factor receptor (HER) family including: HER1 (also known as EGFR), HER2, HER3 and HER4 (also known as ErbB2, ErbB3, and ErbB4 respectively) is an important receptor family for the development of many malignancies. HER3 is overexpressed in breast, lung, gastric, head and neck, ovarian cancer, and melanoma.

The objectives of this clinical study is to determine the safety and tolerability of pING-hHER3FL in patients with advanced or metastatic solid tumor malignancies and to test whether immunization with pING-hHER3FL can cause a HER3 specific immune response in patients. Patients enrolled in the study will receive pING-hHER3FL by intramuscular injection (IM) every 4 weeks for 3 total doses. Potential benefits of the research include learning the safety of a vaccine targeting HER3 expressing cancers, whether the pING-hHER3FL vaccine can induce HER3 specific immune responses, and see possible clinical benefit to patients receiving pING-hHER3FL.”

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Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients”

Conditions: Malignant Head and Neck Neoplasm, Malignant Neoplasm, Metastatic Malignant Neoplasm in the Neck, Metastatic Malignant Neoplasm in the Uterine Cervix, Pancreatic Adenocarcinoma, Pancreatic Neuroendocrine Carcinoma, Recurrent Colorectal Carcinoma, Stage I Colorectal Cancer AJCC v6 and v7, Stage I Hypopharyngeal Carcinoma AJCC v7, Stage I Major Salivary Gland Cancer AJCC v7, Stage I Nasopharyngeal Carcinoma AJCC v7, Stage I Oral Cavity Cancer AJCC v6 and v7, Stage I Oropharyngeal Carcinoma AJCC v6 and v7, Stage II Colorectal Cancer AJCC v7, Stage II Hypopharyngeal Carcinoma AJCC v6 and v7, Stage II Major Salivary Gland Cancer AJCC v7, Stage II Nasopharyngeal Carcinoma AJCC v7, Stage II Oral Cavity Cancer AJCC v6 and v7, Stage II Oropharyngeal Carcinoma AJCC v6 and v7, Stage IIA Colorectal Cancer AJCC v7, Stage IIB Colorectal Cancer AJCC v7, Stage IIC Colorectal Cancer AJCC v7, Stage III Colorectal Cancer AJCC v7, Stage III Hypopharyngeal Carcinoma AJCC v7, Stage III Laryngeal Cancer AJCC v6 and v7, Stage III Major Salivary Gland Cancer AJCC v7, Stage III Nasopharyngeal Carcinoma AJCC v7, Stage III Oral Cavity Cancer AJCC v6 and v7, Stage III Oropharyngeal Carcinoma AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVA Hypopharyngeal Carcinoma AJCC v7, Stage IVA Laryngeal Cancer AJCC v7, Stage IVA Major Salivary Gland Cancer AJCC v7, Stage IVA Nasopharyngeal Carcinoma AJCC v7, Stage IVA Oral Cavity Cancer AJCC v6 and v7, Stage IVA Oropharyngeal Carcinoma AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Stage IVB Hypopharyngeal Carcinoma AJCC v7, Stage IVB Laryngeal Cancer AJCC v7, Stage IVB Major Salivary Gland Cancer AJCC v7, Stage IVB Nasopharyngeal Carcinoma AJCC v7, Stage IVB Oral Cavity Cancer AJCC v6 and v7, Stage IVB Oropharyngeal Carcinoma AJCC v7, Metastatic or Locally Unresectable Solid Tumor

The main goal of this phase of the study is to determine if objectively assessed Physical Activity (PA) levels in advanced-cancer patients are associated with health care provider (HCP)-assessed ECOG performance status and overall survival. The purpose is to advance the evidence-base for incorporating objective assessment of Physical Activity (PA) in the context of performance status assessment in advanced cancer patients.

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Atezolizumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor

Conditions: Non-Small Cell Lung Cancer

This is a Phase II, two part trial (A and B), open label study of Atezolizumab for patients with non-small cell lung cancer (NSCLC) or an advanced solid tumor that has been previously treated with a PD-1 inhibitor (either nivolumab or pembrolizumab).

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Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Conditions: Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Melanoma, Neuroendocrine Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, Primary Brain Tumors, Renal Cell Carcinoma, Sarcomas, Salivary Gland Cancers, Adult Solid Tumor

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

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Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors

Conditions: Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Salivary Gland, Lung Cancer, Breast Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma, Solid Tumor

“This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer.

This study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cells called HER2 chimeric antigen receptor specific cytotoxic T lymphocytes (HER2 specific CAR T cells), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus that is designed to help the immune system including HER2 specific CAR T cell react to the tumor.

The study is looking at combining these two treatments together, because we think that the combination of treatments will work better than each treatment alone. We also hope to learn the best dose level of the treatments and whether or not it is safe to use them together.

In this study, CAdVEC will be injected into participants tumor at one tumor site which is most easiest to reach. Once it infects the cancer cells, activation of the immune response will occur so it can attack and kill cancer cells. (This approach may have limited effects on the other tumor sites that have not received the oncolytic virus injection, so, patients will also receive specific T cells following the intratumor CAdVEC injection.) These T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells.

Investigators want to see if these cells can survive in the blood and affect the tumor. Both CAdVEC and HER2-specific autologous CAR T are investigational products. They are not approved by the FDA.”

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Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer

Conditions: Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer, Head and Neck Cancer, Gastrointestinal Cancer

The purpose of this research is to understand if it is helpful for patients with mental illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.

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CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Conditions: Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, Head and Neck Cancer

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

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Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

Conditions: Metastatic Castrate Resistant Prostate Cancer, BRCA1, BRCA2, PALB2 Genetic Mutations

“This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BRCA1, BRCA2 or PALB2 inactivating DNA mutations.

Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28 day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria.

Participants then crossover from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.”

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CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Conditions: HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer, Bladder Cancer, Breast Cancer, Breast Neoplasm, Carcinoma, Ductal, Carcinoma, Hepatocellular, Cancer, Lung Cancer, Non-Small-Cell, Carcinoma, Ovarian Epithelial, Carcinoma, Small Cell, Carcinoma, Squamous, Carcinoma, Transitional Cell, Colorectal Cancer, Esophagogastric Junction Neoplasms, Inflammatory Breast Cancer, Stomach Neoplasms, Malignant Neoplasms, Ovarian Neoplasms, Pancreatic Cancer, HER2-positive Solid Tumors, HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, Prostate Cancer, Head and Neck Cancer, Endometrial Cancer, Lung Cancer, Small Cell

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

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COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.

Conditions: Endometrial Neoplasms, Ovarian Cancer, Solid Tumor, Head and Neck Cancer

This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.

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Comparison of Perioperative Outcomes Between Minimally Invasive and Open Pancreaticoduodenectomy

Conditions: Pancreaticoduodenectomy

The phase 3 randomized trial is to compare perioperative outcomes between minimally invasive and open approach for pancreaticoduodenectomy

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CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

Conditions: Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Cervical Cancer, Ovarian Cancer, Pancreatic Cancer, Endometrial Cancer, Sarcoma, Squamous Cell Carcinoma of the Head and Neck, Bladder Cancer, Metastatic Castration Resistant Prostate Cancer, Non-hodgkin Lymphoma

This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.

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Dose Escalation and Dose Expansion Study of CPO-100 in Patients With Advanced Solid Tumors

Conditions: Solid Tumor

This is an open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) in adult patients with advanced solid tumors. The second part of the study will further evaluate the safety and tolerability of as well as antitumor activity at the recommended dose from the dose escalation phase.

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Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

Conditions: Solid Tumor, Melanoma, Renal Cell Carcinoma, Urothelial Carcinoma, Lung Cancer, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer, Gastric Cancer, Ovarian Cancer, Prostate Cancer, Triple Negative Breast Cancer, Endometrial Cancer

This study is a Phase 1/2, open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab.

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Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use

Conditions: Lung Non-Small Cell Carcinoma, Head and Neck Squamous Cell Carcinoma

This trial studies how well an enhanced tobacco intervention protocol (ETIP) works compared to standard treatment in helping head and neck and lung cancer patients starting treatment to reduce cigarette use. ETIP is an evidence-based tobacco cessation program including specialized one-to-one and telehealth counseling, drug therapy, nicotine replacement therapy, and frequent patient follow up. ETIP may help reduce smoking and improve cessation in patients with head and neck squamous cell cancer or non-small cell lung cancer.

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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (innovaTV 207)

Conditions: Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Exocrine Pancreatic Cancer, Carcinoma, Squamous Cell of Head and Neck

This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are three parts to this study. In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. In Part C, participants may receive tisotumab vedotin on Days 1 and 15 or Days 1, 8, and 15 on a 4-week cycle.

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Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck

Conditions: Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.

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Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients

Conditions: Cancer, Cancer Metastatic, Neoplasms, Breast Cancer, Lung Cancer, Glioblastoma, Prostate Cancer, Gynecologic Cancer, Colorectal Cancer, Sarcoma, Kidney Cancer, Bladder Cancer, Lymphoma, Leukemia, Head and Neck Cancer, Pancreas Cancer, Multiple Myeloma, Anxiety, Social Isolation, Stress, Loneliness, Melanoma, Uterine Cancer

This is a single-arm, prospective, interventional study in cancer survivors and patients to examine the feasibility of a mobile health application, Elly (Elly Health Inc.), to reduce levels of anxiety, stress, loneliness, and social isolation. Participants will be given access to the Elly phone application developed by Elly Health Inc. and will be asked to complete questionnaires measuring quality of life at multiple timepoints during the study.

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Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

Conditions: Breast Carcinoma, Colon Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Head and Neck Carcinoma, Kidney Carcinoma, Lung Carcinoma, Ovarian Carcinoma, Pancreatic Carcinoma, Solid Neoplasm, Uterine Corpus Cancer

This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient’s body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo a second PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients can decide to have only the FAPI PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi. Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient’s body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

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First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

Conditions: Clear Cell Renal Cell Cancer, Non-Small-Cell Lung Cancer, Triple Negative Breast Neoplasms, Squamous Cell Cancer of Head and Neck, Small Cell Lung Cancer, Gastroesophageal Cancer, Melanoma, Cervical Cancer, Advanced Solid Tumours

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

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First-in-human Study of DRP-104 (Sirpiglenastat) as Single Agent and in Combination With Atezolizumab in Patients With Advanced Solid Tumors.

Conditions: Advanced Solid Tumor, Non-Small Cell Lung Cancer Recurrent, Squamous Cell Carcinoma of Head and Neck, Non Small Cell Lung Cancer Metastatic

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmaco-dynamics and preliminary anti-tumor activity of DRP-104 (sirpiglenastat) administered via intravenous infusion or via subcutaneous injection as a single agent and in combination with atezolizumab in patients with advanced solid tumors and to assess preliminary safety and efficacy of which route of administration (intravenous or subcutaneous) will be selected for further development for the other two expansions of patients, advanced non-small cell lung cancer (NSCLC) with defined genetic mutations, and advanced squamous cell carcinoma of the head and neck (SCCHN).

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FS118 First in Human Study in Patients With Advanced Malignancies

Conditions: Advanced Cancer, Metastatic Cancer, Squamous Cell Carcinoma of Head and Neck

This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and neck (SCCHN). Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

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FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

Conditions: Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, EGFR Positive Solid Tumor, HER2-positive Breast Cancer, Hepatocellular Carcinoma, Small Cell Lung Cancer, Renal Cell Carcinoma, Pancreas Cancer, Melanoma, NSCLC, Urothelial Carcinoma, Cervical Cancer, Microsatellite Instability, Merkel Cell Carcinoma

FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.

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GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma

Conditions: Pancreatic Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Triple Negative Breast Cancer, Castration-resistant Prostate Cancer, Microsatellite Stable Colorectal Cancer, Non-small Cell Lung Cancer, Small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma, Renal Cell Carcinoma, Hepatocellular Carcinoma

This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors

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GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

Conditions: Solid Tumor, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma

This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.

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GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

Conditions: Malignant Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC)

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors

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GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Conditions: Solid Tumors, Non-small Cell Lung Cancer, Urothelial Carcinoma, Endometrial Carcinoma, Triple Negative Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, Cervical Cancer

The purpose of the trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors

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Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients

Conditions: Breast Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Prostate Cancer, Lung Cancer, Ovarian Cancer

The basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory study designed to generate hypotheses for further research.

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IACS-6274 With or Without Pembrolizumab for the Treatment of Advanced Solid Tumors

Conditions: Advanced Endometrial Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma, Advanced Ovarian Clear Cell Adenocarcinoma, Chondrosarcoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Refractory Endometrial Carcinoma, Refractory Head and Neck Squamous Cell Carcinoma, Refractory High Grade Ovarian Serous Adenocarcinoma, Refractory Melanoma, Refractory Ovarian Clear Cell Adenocarcinoma, Stage III Ovarian Cancer AJCC v8, Stage III Uterine Corpus Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA Uterine Corpus Cancer AJCC v8, Stage IIIA1 Ovarian Cancer AJCC v8, Stage IIIA2 Ovarian Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIB Uterine Corpus Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Uterine Corpus Cancer AJCC v8, Stage IIIC1 Uterine Corpus Cancer AJCC v8, Stage IIIC2 Uterine Corpus Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Uterine Corpus Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Uterine Corpus Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Uterine Corpus Cancer AJCC v8

This phase I trial tests the safety, side effects, and best dose of IACS-6274 with or without pembrolizumab in treating patients with solid tumors that have spread to other places in the body (advanced). IACS-6274 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving IACS-6274 with or without pembrolizumab may help to control the disease.

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INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

Conditions: Ovarian Cancer, Bladder Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer, Castration Resistant Prostate Cancer

This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, or bladder cancer

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Jump: MR Simulation For Radiation Therapy Master Protocol

Conditions: Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck Cancer

This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.

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LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of Lerapolturev (PVSRIPO) and Lerapolturev in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors

Conditions: Solid Tumor, Bladder Cancer, Head and Neck Cancer

This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which will be referred to throughout this protocol as “anti-PD-1/L1 therapy”) therapy in adult patients with solid tumor cancers. Bladder Cancer and Head and Neck Squamous Cell Carcinoma have been selected as the first tumor specific cancers of interest for enrollment.

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Mapping Draining Lymph Nodes in CNS Malignancies

Conditions: Central Nervous System Neoplasms, Central Nervous System Tumor

The purpose of this research study is to determine whether the lymph nodes that drain a brain tumor can be detected by imaging after injection of a substance called Tc-99m tilmanocept directly into the brain tissue around the tumor. Tc-99m tilmanocept is a radioactive substance that is used to find lymph nodes by injecting it and then scanning the body with a device that can trace its radioactivity. In this study, the investigators are looking to see how long it takes the Tc-99m tilmanocept to travel from the tumor to the lymph nodes. The investigators will be using it to map lymph nodes as they relate to specific brain areas.

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MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005)

Conditions: Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Gallbladder Neoplasms, Cholangiocarcinoma, Esophageal Neoplasms, Triple Negative Breast Neoplasms, Hepatocellular Carcinoma

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

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NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Conditions: Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Stomach (Disorder), Squamous Cell Carcinoma of Head and Neck, Metastasis From Malignant Tumor of Cervix, Metastatic Squamous Cell Carcinoma, Metastasis From Malignant Melanoma of Skin (Disorder), Merkel Cell Carcinoma (Disorder), Metastasis From Malignant Tumor of Lung, Metastasis From Malignant Tumor of Bladder (Disorder)

The 1100 study is an open-label, Phase I, prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.

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Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC

Conditions: Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma

“The primary objective of the study is to evaluate the clinical activity of neoadjuvant cemiplimab therapy in patients with resectable Non-small cell lung cancer (NSCLC), Hepatocellular carcinoma (HCC), and Head and neck squamous cell carcinoma (HNSCC) lesions, as measured by pathological evaluations of resected tumors.

The secondary objectives of the study are:

To assess the anti-tumor activity of neoadjuvant and adjuvant cemiplimab therapy as defined by multiple criteria
To determine the safety and tolerability of neoadjuvant and adjuvant cemiplimab therapy including delay to surgery
To assess the change in tumor-infiltrating CD8 T-cell density and to explore the correlation to the pathological response to therapy”

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Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

Conditions: Acinar Cell Carcinoma, Adenoid Cystic Carcinoma, Adrenal Cortex Carcinoma, Adrenal Gland Pheochromocytoma, Anal Canal Neuroendocrine Carcinoma, Anal Canal Undifferentiated Carcinoma, Angiosarcoma, Apocrine Neoplasm, Appendix Mucinous Adenocarcinoma, Bartholin Gland Transitional Cell Carcinoma, Basal Cell Carcinoma, Bladder Adenocarcinoma, Breast Metaplastic Carcinoma, Cervical Adenocarcinoma, Cholangiocarcinoma, Chordoma, Colorectal Squamous Cell Carcinoma, Desmoid Fibromatosis, Endometrial Transitional Cell Carcinoma, Endometrioid Adenocarcinoma, Esophageal Neuroendocrine Carcinoma, Esophageal Undifferentiated Carcinoma, Extrahepatic Bile Duct Carcinoma, Extramammary Paget Disease, Fallopian Tube Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fibromyxoid Tumor, Gallbladder Carcinoma, Gastric Neuroendocrine Carcinoma, Gastric Squamous Cell Carcinoma, Gastric Undifferentiated Carcinoma, Gastrointestinal Stromal Tumor, Gestational Trophoblastic Tumor, Giant Cell Carcinoma, Human Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-Type, Intestinal Neuroendocrine Carcinoma, Intrahepatic Cholangiocarcinoma, Lung Carcinoid Tumor, Lung Sarcomatoid Carcinoma, Major Salivary Gland Carcinoma, Malignant Odontogenic Neoplasm, Malignant Peripheral Nerve Sheath Tumor, Malignant Solid Neoplasm, Malignant Testicular Sex Cord-Stromal Tumor, Metastatic Malignant Neoplasm of Unknown Primary, Minimally Invasive Lung Adenocarcinoma, Mixed Mesodermal (Mullerian) Tumor, Mucinous Adenocarcinoma, Mucinous Cystadenocarcinoma, Nasal Cavity Adenocarcinoma, Nasal Cavity Carcinoma, Nasopharyngeal Carcinoma, Nasopharyngeal Papillary Adenocarcinoma, Nasopharyngeal Undifferentiated Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Undifferentiated Carcinoma, Ovarian Adenocarcinoma, Ovarian Germ Cell Tumor, Ovarian Mucinous Adenocarcinoma, Ovarian Squamous Cell Carcinoma, Ovarian Transitional Cell Carcinoma, Pancreatic Acinar Cell Carcinoma, Pancreatic Neuroendocrine Carcinoma, Paraganglioma, Paranasal Sinus Adenocarcinoma, Paranasal Sinus Carcinoma, Parathyroid Gland Carcinoma, PEComa, Peritoneal Mesothelioma, Pituitary Gland Carcinoma, Placental Choriocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Pseudomyxoma Peritonei, Rare Disorder, Scrotal Squamous Cell Carcinoma, Seminal Vesicle Adenocarcinoma, Seminoma, Serous Cystadenocarcinoma, Small Intestinal Adenocarcinoma, Small Intestinal Squamous Cell Carcinoma, Spindle Cell Neoplasm, Squamous Cell Carcinoma of the Penis, Teratoma With Somatic-Type Malignancy, Testicular Non-Seminomatous Germ Cell Tumor, Thyroid Gland Carcinoma, Tracheal Carcinoma, Transitional Cell Carcinoma, Ureter Adenocarcinoma, Ureter Squamous Cell Carcinoma, Urethral Adenocarcinoma, Urethral Squamous Cell Carcinoma, Vaginal Adenocarcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified, Vulvar Carcinoma

This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers

Conditions: Bronchial Dysplasia, Tobacco Smoking, History of Non-Small Cell Lung Cancer, History of Head and Neck Cancer

The goal of this clinical research study is to determine whether the PD-1 inhibitor (Programmed cell death protein 1) nivolumab improves premalignant bronchial dysplastic lesions in subjects that are at high risk for the development of lung cancer, including those with a prior smoking history, or history of lung cancer or head and neck cancer. The safety and tolerability of nivolumab will also be studied.

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Onco-primary Care Networking to Support TEAM-based Care

Conditions: Blood Pressure, Hypertension, Cancer, Cancer, Breast, Cancer of Prostate, Cancer Colorectal, Cancer, Endometrial, Cancer of Head and Neck, Non Small Cell Lung Cancer, CVD – Cardiovascular Disease, Diabetes Mellitus, Hypercholesterolemia, Diabetes, Cancer of Esophagus, Cancer of Liver, Cancer, Renal Cell, Cancer of Pancreas, Cancer Ovaries

“The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with >1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be ~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers.

A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.”

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Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers

Conditions: Breast Cancer, Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Hepatocellular Cancer, Colorectal Cancer, Gastric Adenocarcinoma, Melanoma, Advanced Cancer

Many patients have cancers that have increased activity of a protein called STAT3 that contributes critically to the development and growth of their cancer. Despite our knowledge of STAT3’s importance to cancer, scientists and doctors have not developed a drug that targets it and that patients can take to treat their cancer more effectively than treatments that are now available. Tvardi Therapeutics, Incorporated has developed a compound, TTI-101, which can be given by mouth and acts as a direct inhibitor of STAT3. Administration of TTI-101 to mice demonstrated that it blocked growth of cancers of the breast, head and neck, lung, and liver and it was safe when administered at high doses to mice, rats, and dogs. In this application, Tvardi is proposing to further develop TTI-101 for treatment of solid tumors for which the prognosis is dismal. The investigators will determine how safe it is when administered to patients with cancer, determine whether an adequate dose can be administered to patients with cancer that will block STAT3 in their cancer, and determine whether treatment with TTI-101 leads to reduced growth of their cancer.

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Oral TrkA Inhibitor VMD-928 for Treatment of Advanced Adult Solid Tumors or Lymphoma

Conditions: Thymic Carcinoma and Thymoma, Mesothelioma, Head and Neck Squamous Cell Carcinoma, Ovarian Cancer, Hepatocellular Carcinoma, Squamous Cell Carcinoma of Lung, Esophageal Cancer, Adenoid Cystic Carcinoma, Prostate Cancer, Cervical Cancer, Gastric Cancer, Melanoma, Acute Myeloid Leukemia, Non Hodgkin Lymphoma

This is a multicenter, open-label, Phase 1 study of orally administered VMD-928 in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists

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Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

Conditions: Solid Tumor

This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.

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Phase 1 Study of BAY1905254 – An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.

Conditions: Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma

This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab. The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it affects the body and to try to find the best dose of the new drug to give to participants and to obtain a preliminary assessment of the tumor response efficacy in the recurrent or metastatic Head and Neck Cancer.

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Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

Conditions: RET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer, RET-altered Papillary Thyroid Cancer, RET-altered Colon Cancer, RET-altered Solid Tumors, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Thyroid Diseases, Thyroid Neoplasm, Thyroid Cancer, Papillary, Carcinoma, Neuroendocrine, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Disease, Carcinoma, Bronchogenic, Bronchial Neoplasms, Endocrine System Diseases, Endocrine Gland Neoplasm, Head and Neck Neoplasms, Adenocarcinoma, Papillary, Adenocarcinoma, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neuroendocrine Tumors, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue, Colonic Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasm, Digestive System Disease, Gastrointestinal Disease, Colonic Diseases, Intestinal Disease

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in patients with medullary thyroid cancer, RET-altered NSCLC and other RET-altered solid tumors.

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Phase 1a and Phase 2 Study for PK, PD, Safety and Preliminary Efficacy of ST-067

Conditions: Cancer, Solid Tumor, Melanoma, Renal Cell Carcinoma, Triple-negative Breast Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Carcinoma

This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of ST-067. Phase 1a is a first-in-human (FIH) dose escalation study in patients aged 18 years or older diagnosed with solid tumors who have exhausted available standard. Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and microsatellite instability-high tumors.

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Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors

Conditions: Solid Tumor, Colorectal Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Endometrial Cancer, Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma, Solid Tumors With PIK3Ca Mutation

This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single agent and in combination with pembrolizumab to determine its maximum tolerated dose (MTD) and or recommended Phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity in subjects with advanced solid tumors. Subjects with all histologic types of solid tumors are eligible for the escalation and dose-finding portions of the study. However, the preferred tumor types for enrollment are colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial cancer, endometrial cancer, and gastroesophageal junction (GEJ) or gastric adenocarcinoma. Enrollment in the expansion cohorts is limited to the following tumor types: endometrial, SCCHN, CRC, and a basket cohort in subjects selected for an activating mutation in PIK3Ca.

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Phase Ib of L-NMMA and Pembrolizumab

Conditions: Non-Small Cell Lung Cancer, Malignant Melanoma, Head and Neck Squamous Cell Carcinoma, Classical Hodgkin Lymphoma, Urothelial Carcinoma Bladder, DNA Repair-Deficiency Disorders

The purpose of this Phase Ib study is to test the safety of NG-monomethyl-L-arginine (L-NMMA) and pembrolizumab when used together in participants with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma (cHL), urothelial carcinoma, or microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) cancer. Pembrolizumab is a type of treatment that stimulates the immune system to attack cancer cells. The immune system is normally the body’s first defense against threats like cancer. However, sometimes cancer cells produce signals like programmed death-1 (PD-1) that prevent the immune system from detecting and killing them. Pembrolizumab blocks PD-1 so your immune system can detect and attack cancer cells. To help further boost the cancer-fighting ability of your immune system, L-NMMA will be used along with pembrolizumab. L-NMMA is a nitric oxide synthase inhibitor. The presence of nitric oxide synthase in the area around the cancer cells blocks the cancer-fighting ability of the immune system. Thus, the use of L-NMMA and pembrolizumab together may make the immune system work harder to attack and destroy the cancer cells.

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Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Conditions: Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal SCC, Gastrointestinal Stromal Tumors, Colorectal Cancer

“This study is a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.

These two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.

The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.”

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Priming Immunotherapy in Advanced Disease With Radiation

Conditions: Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck

“This study proposes to treat metastatic non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC) patients who are already initiating an immune checkpoint inhibitor (such as Nivolumab, Atezolizumab or Pembrolizumab) for disease treatment as per FDA approved guidelines. In these patients we will deliver a short-course radiation to a single systemic (non-CNS) site within 14 days of receiving the first dose of immune checkpoint inhibitors. This sequence allows radiation to release tumor antigens from immune inaccessible areas such as necrotic tumor or low perfusion to provide a robust anti-tumor immune response with immune checkpoint inhibitors.

The primary objective is to assess six-month progression free survival (PFS) compared to historical control.”

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Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study

Conditions: Breast Carcinoma, Digestive System Neoplasm, Malignant Brain Neoplasm, Malignant Central Nervous System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Genitourinary System Neoplasm, Malignant Head and Neck Neoplasm, Malignant Musculoskeletal Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm of Unknown Primary, Skin Carcinoma

This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent’s Riverside. This may help doctors better understand and/or treat others who have genetic mutations.

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PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL

Conditions: Solid Tumor, Adult, Head and Neck Cancer, Non-Small Cell Lung Cancer, Diffuse Large B Cell Lymphoma, Esophageal Cancer

The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). The antitumor activity of CX-2029 will be evaluated in subjects with head and neck squamous cell carcinoma (HNSCC), DLBCL, non-small cell lung cancer (NSCLC) (squamous cell histology only), or esophageal (esophageal adenocarcinoma [EAC], esophageal squamous cell carcinoma [ESCC], or gastroesophageal [GE] junction) cancer.
PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc

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RAPA-201 Therapy of Solid Tumors

Conditions: Solid Tumor, Breast Cancer, Small Cell and Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Cancer, Esophageal Adenocarcinoma, Gastric Junction Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Head and Neck Cancer, Squamous Cell Carcinoma of Oral Cavity, Squamous Cell Carcinoma of Larynx, Squamous Cell Carcinoma of Nasopharynx, Squamous Cell Carcinoma of Other Specified Sites of Skin, Carcinoma of Unknown Primary, Bladder Cancer, Malignant Melanoma

“The therapy of solid tumors has been revolutionized by immune therapy, in particular, approaches that activate immune T cells in a polyclonal manner through blockade of checkpoint pathways such as PD-1 by administration of monoclonal antibodies. In this study, the investigators will evaluate the adoptive transfer of RAPA-201 cells, which are checkpoint-deficient polyclonal T cells that represent an analogous yet distinct immune therapy treatment platform for solid tumors.

RAPA-201 is a second-generation immunotherapy product consisting of reprogrammed autologous CD4+ and CD8+ T cells of Th1/Tc1 cytokine phenotype. First-generation RAPA-101, which was bred for resistance to the mTOR inhibitor rapamycin, demonstrated clear anti-tumor effects in multiple myeloma patients without any product-related adverse events. Second-generation RAPA-201, which have acquired resistance to the mTOR inhibitor temsirolimus, are manufactured ex vivo from peripheral blood mononuclear cells collected from solid tumor patients using a steady-state apheresis. RAPA-201 is also being evaluated for the therapy of relapsed, refractory multiple myeloma and was granted Fast Track Status by the FDA for this indication. The novel RAPA-201 manufacturing platform, which incorporates both an mTOR inhibitor (temsirolimus) and an anti-cancer Th1/Tc1 polarizing agent (IFN-alpha) generates polyclonal T cells with five key characteristics:

Th1/Tc1: polarization to anti-cancer Th1 and Tc1 subsets, with commensurate down-regulation of immune suppressive Th2 and regulatory T (TREG) subsets;
T Central Memory: expression of a T central memory (TCM) phenotype, which promotes T cell engraftment and persistence for prolonged anti-tumor effects;
Temsirolimus-Resistance: acquisition of temsirolimus-resistance, which translates into a multi-faceted anti-apoptotic phenotype that improves T cell fitness in the stringent conditions of the tumor microenvironment;
T Cell Quiescence: reduced T cell activation, as evidence by reduced expression of the IL-2 receptor CD25, which reduces T cell-mediated cytokine toxicities such as cytokine-release syndrome (CRS) that limit other forms of T cell therapy; and
Reduced Checkpoints: multiple checkpoint inhibitory receptors are markedly reduced on RAPA-201 cells (including but not limited to PD-1, CTLA4, TIM-3, LAG3, and LAIR1), which increases T cell immunity in the checkpoint-replete, immune suppressive tumor microenvironment.
This is a Simon 2-stage, non-randomized, open label, multi-site, phase I/II trial of RAPA-201 T immune cell therapy in patients with advanced metastatic, recurrent, and unresectable solid tumors that have recurred or relapsed after prior immune therapy. Patients must have tumor relapse after at least one prior line of therapy and must have refractory status to the most recent regimen, which must include an anti-PD-(L)1 monoclonal antibody. Furthermore, accrual is limited to solid tumor disease types potentially amenable to standard-of-care salvage chemotherapy consisting of the carboplatin + paclitaxel (CP) regimen that will be utilized for host conditioning prior to RAPA-201 therapy. Importantly, carboplatin and paclitaxel are “”immunogenic”” chemotherapy agents whereby the resultant cancer cell death mechanism is favorable for generation of anti-tumor immune T cell responses. Thus, the CP regimen that this protocol incorporates is intended to directly control tumor progression and indirectly promote anti-tumor T cell immunity. The CP regimen is considered standard-of-care therapy for the following tumor types, which will be focused upon on this RAPA-201 protocol: small cell and non-small cell lung cancer; breast cancer (triple-negative sub-type or relapse after ovarian ablation/suppression); gastric cancer (esophageal and esophageal-gastric-junction adenocarcinoma; gastric adenocarcinoma; esophageal squamous cell carcinoma); head and neck cancer (squamous cell carcinoma of oral cavity, larynx, nasopharynx, and other sites); carcinoma of unknown primary; bladder cancer; and malignant melanoma.

Protocol therapy consists of six cycles of standard-of-care chemotherapy (carboplatin + paclitaxel (CP) regimen) administered every 28 days (chemotherapy administered on cycles day 1, 8, and 15). RAPA-201 cells will be administered at a target flat dose of 400 X 10^6 cells per infusion on day 3 of cycles 2 through 6.

A sample size of up to 22 patients was selected to determine whether RAPA-201 therapy, when used in combination with the CP regimen, represents an active regimen in solid tumors that are resistant to anti-PD(L)-1 checkpoint inhibitor therapy, as defined by a response rate (≥ PR) consistent with a rate of 35%. The first stage of protocol accrual will consist of n=10 patients; to advance to the second protocol accrual stage, RAPA-201 therapy must result in a tumor response (≥ PR) in at least 2 out of the 10 initial patients.

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RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors (HNSCC, Cervical) and Melanoma

Conditions: Head and Neck Squamous Cell Carcinoma, Melanoma, Cervical Cancer

The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6/E7 positive tumors (HNSCC, cervical) and melanoma.

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RTX-321 Monotherapy in Patients With HPV 16+ Tumors

Conditions: Cervical Cancer, Head and Neck Cancer, Anal Cancer

This is an open-label, multicenter, multiple-ascending dose, FIH, Phase 1 study of RTX-321 for the treatment of patients that are HLA-A*02:01 positive with persistent, recurrent, or metastatic, unresectable, HPV 16+ cancers.

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Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer

Conditions: Squamous Cell Carcinoma of Head and Neck, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Esophageal Cancer, Gastric Cancer, Melanoma, Renal Cell Carcinoma, Pancreatic Cancer, Cervical Cancer, Triple Negative Breast Cancer, Advanced Cancer, Metastatic Cancer

A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.

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Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.

Conditions: Solid Tumor, Lymphoma

This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers. Comparison will be made to historical data. General safety and efficacy using RECIST 1.1 and Immune-Related Response Criteria as well as ECOG performance will be utilized.

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Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Conditions: Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Metastatic Prostate Cancer, Ovarian Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Merkel Cell Carcinoma, Pancreas Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer

This is a First-in-Human Phase IA/IB open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

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Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers

Conditions: Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Advanced Solid Tumor, Refractory Tumor, Metastatic Tumor

This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.

Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients

Conditions: Colorectal Cancer, Head and Neck Cancer

The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.

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SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas

Conditions: Squamous Cell Carcinoma of the Head and Neck, Melanoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Squamous Cell Carcinoma of the Anus, Squamous Cell Carcinoma of the Cervix, Squamous Cell Carcinoma of the Skin, Renal Cell Carcinoma, Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Mismatch Repair Deficient or MSI-High Solid Tumors

This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.

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Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors

Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Urothelial Carcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Urothelial Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Gastric Cancer AJCC v8, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIA Gastric Cancer AJCC v8, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIB Gastric Cancer AJCC v8, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIC Gastric Cancer AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Gastric Cancer AJCC v8, Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Recurrent Head and Neck Squamous Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Unresectable Malignant Solid Neoplasm, Unresectable Melanoma

This phase I trial studies the best dose of sonidegib when given together with pembrolizumab and to see how well they work in treating patients with solid tumor that has spread to other places in the body (advanced). Sonidegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sonidegib and pembrolizumab may work better than standard treatment in treating patients with advanced solid tumors.

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Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene

Conditions: HER2-positive Breast Cancer, HER2 Gene Mutation,HER-2 Gene Amplification,HER2 Positive Gastric Cancer, Salivary Gland Cancer, Salivary Gland Tumor, Salivary Gland Carcinoma, Salivary Gland Neoplasms, Lung Cancer, Colo-rectal Cancer, Rare Diseases, Solid Tumor, Recurrent Gastric Cancer, Recurrent Colon Cancer, Recurrent Breast Cancer, Head and Neck Cancer, Head and Neck Carcinoma, Bladder Cancer, Cervical Cancer, Liver Cancer, Bile Duct Cancer, Urologic Cancer, Pancreatic Cancer, Prostate Cancer, Recurrent Prostate Cancer, Rectal Cancer, Recurrent Ovarian Carcinoma, Recurrent Renal Cell Cancer, Rectal Cancer Stage II, Rectal Cancer Stage I, Rectal Cancer Stage III, Skin Cancer, Mouth Cancer, Lip Cancer Stage I, Tongue Cancer, Breast Neoplasm Malignant Primary, Larynx Cancer, Tonsil Cancer, Palate Cancer, Mucoepidermoid Carcinoma, Primary Peritoneal Carcinoma, Mucinous Adenocarcinoma Gastric, Mucinous Breast Cancer Recurrent, Cholangiocarcinoma

Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Patients will receive study drug as a single IV infusion. Cycles will continue until disease progression or unacceptable toxicity.

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Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

Conditions: Advanced Solid Tumors With Literature Evidence of CD25(+) Treg Content, Head and Neck Cancer, Non-small Cell Lung Cancer, Gastric Cancer, Esophageal Cancer, Pancreas Cancer, Bladder Cancer, Renal Cell Carcinoma, Melanoma, Triple-negative Breast Cancer, Ovarian Cancer

This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.

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Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Conditions: Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck, Non-small Cell Lung Cancer

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.

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Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Conditions: Advanced Solid Tumor

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

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Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

Conditions: Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Castration-resistant Prostate Cancer, Triple Negative Breast Cancer, Ovarian Cancer, Endometrial Cancer, Hepatocellular Carcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Colorectal Cancer, Head and Neck Cancer, Differentiated Thyroid Cancer

This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer and gastroesophageal junction cancer (GC/GEJC), colorectal cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Two exploratory single-agent cabozantinib (SAC) cohorts will also be enrolled with UC or NSCLC subjects.

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Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

Conditions: Advanced Cancer, Lung Cancer, Head and Neck Cancer, Melanoma

This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.: EOS-448 will be combined with pembrolizumab, a marketed anti-PD-1 antibody in one treatment arm and a second treatment arm will evaluate EOS-448 combined with inupadenant, an investigational adenosine A2A receptor antagonist.

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Study of INBRX-105 in Patients With Solid Tumors

Conditions: Metastatic Solid Tumors, Non-small Cell Lung Cancer, Melanoma, Head and Neck Squamous Cell Carcinoma, Gastric Adenocarcinoma, Renal Cell Carcinoma, Urothelial Carcinoma, Esophageal Adenocarcinoma

This is a first-in-human, open-label, nonrandomized, four-part Phase 1 trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism.

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

Conditions: Solid Tumor, Non-Small Cell Lung Cancer, Melanoma, Head and Neck Cancer, Gastric Cancer, Renal Cell Carcinoma, Urothelial Carcinoma

This is a first-in-human, open-label, non-randomized, 4-part Phase 1 trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda).

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Study of INCA 0186 in Subjects With Advanced Solid Tumors

Conditions: Advanced Solid Tumors, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Gastrointestinal (GI) Malignancies

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.

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Study of MT-6402 in Subjects With Advanced Solid Cancer That Expresses PD-L1

Conditions: Advanced Solid Tumor, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck

This will be a Phase 1 Open-label, dose escalation and expansion study of MT-6402 (an Engineered Toxin Body (ETB)) in subjects with advanced solid cancer that expresses PD-L1

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Study of NEO-201 in Solid Tumors Expansion Cohorts

Conditions: Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Cancer, Uterine Cancer

“The open label, first-in-human, phase 1, dose escalation component in refractory solid tumors has been completed. The Maximum Tolerated Dose and Recommended Phase 2 Dose (RP2D) was determined to be 1.5mg/kg.

The Expansion Phase of this study is currently enrolling subjects with non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical and uterine cancers who progressed on front line therapy. Subjects will be treated with NEO-201 at the RP2D (1.5 mg/kg) every 2 weeks in combination with pembrolizumab, given 1 day after the NEO-201, at 400 mg IV every 6 weeks.”

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Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Conditions: Mesothelioma, Glioblastoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Cholangiocarcinoma, Breast Cancer, Ovarian Cancer, Cervical Cancer, Endocervical Cancer, Colorectal Cancer, Esophageal Cancer

Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

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Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Cancer (CRC)

This is a Phase 1b/2, open-label multicenter study evaluating NKTR-255 as a monotherapy and together with cetuximab in patients with head and neck squamous cell carcinoma (HNSCC), colorectal carcinoma (CRC), cutaneous squamous cell carcinoma (cSCC), anal cell carcinoma (ASCC) and cervical cancer. The recommended phase 2 dose of NKTR-255, determined in the dose escalation phase (Phase 1b), will be used to treat patients in Phase 2 of this study.

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Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors

Conditions: Cancer, Melanoma, Solid Tumor, Squamous Cell Carcinoma of Head and Neck, Breast Cancer, Advanced Solid Tumor, Triple Negative Breast Cancer, Colorectal Carcinoma, Non-melanoma Skin Cancer, Liver Metastases

ONCR-177-101 is a phase 1, open-label, multi-center, dose escalation and expansion study of ONCR-177, an oncolytic Herpes Simplex Virus for intratumoral injection, alone and in combination with PD-1 blockade in adult subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with Liver Metastases of Solid Tumors. The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

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Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

Conditions: Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Lung Squamous Cell Carcinoma, Pancreatic Cancer, Bile Duct Cancer, Endometrial Cancer, Melanoma Cancer, Urothelial Cancer

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC – clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 2 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

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Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

Conditions: Renal Cell Cancer, Melanoma, Non-Small-Cell Lung Cancer, Hepatocellular Cancer, Bladder Cancer, Sarcoma, Head and Neck Cancer, Colorectal Cancer, Ovarian Cancer, Squamous Cell Carcinoma

“This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 [PD-1] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them.

The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.”

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Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors

Conditions: Metastatic Solid Tumor

The primary objective of this study is to to assess the objective response rate (ORR) of sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.

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Study of Safety and Tolerability of BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-driven Advanced Solid Tumors

Conditions: TNBC – Triple-Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Uveal Melanoma, Colorectal Cancer, Chordoma, Squamous Cell Carcinoma of the Lung, EGFR Amplification, Epithelial Ovarian Cancer, Pancreas Cancer, Cutaneous Squamous Cell Carcinoma

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

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Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors

Conditions: Locally Advanced Solid Tumor, Metastatic Solid Tumor, Pancreatic Cancer, Lung Cancer, Head and Neck Cancer, Breast Cancer, Kidney Cancer, Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Sarcoma, Gallbladder Cancer, Bile Duct Cancer, Esophageal Cancer, Uterine Cancer, Cholangiocarcinoma, Prostate Cancer

This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.

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Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors

Conditions: Thyroid, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Bladder Cancer, Melanoma, Merkel Cell Carcinoma, Skin Squamous Cell Carcinoma, Microsatellite Instability High, Triple Negative Breast Cancer, Mesothelioma, Thymic Cancer, Cervical Cancer, Biliary Tract Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Gastric Cancer, Head and Neck Squamous Cell Carcinoma, Anal Cancer

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

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Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Conditions: Adult Solid Tumor

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

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Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Conditions: Adult Solid Tumor

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

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Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

Conditions: Lung Cancer Squamous Cell, Solid Tumors, Head & Neck Cancer, Pancreatic Cancer

This research study is studying a combination of drugs as a possible treatment for cancer that might have a specific change in the phosphatidylinositol-3 phosphate (PI3K) pathway.

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Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Pembrolizumab or Budigalimab

Conditions: Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma

“Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of ABBV-514 as a monotherapy and in combination with Pembrolizumab or Budigalimab.

Budigalimab and ABBV-514 are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Pembrolizumab is a drug approved for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) of ABBV-514 will be explored. Each treatment arm receives a different doses of ABBV-514 in monotherapy and in combination with Pembrolizumab or Budigalimab. Approximately 136 adult participants will be enrolled in the study across approximately 80 sites worldwide.

Participants will receive ABBV-514 as a monotherapy or in combination with Pembrolizumab or Budigalimab as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.”

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Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

Conditions: Locally Advanced or Metastatic Solid Tumors

The primary objective of this study is to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.

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Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors

Conditions: Non-small-cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Urothelial Carcinoma, Colorectal Carcinoma, Ovarian Carcinoma

“This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy.

The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.”

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Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.

Conditions: Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Ovarian Cancer

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07257876, a CD47-PD-L1 bispecific antibody, in participants with selected advanced or metastatic tumors for whom no standard therapy is available. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07257876, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

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Supportive Oncology Care At Home RCT

Conditions: Pancreatic Cancer, GastroEsophageal Cancer, Rectal Cancer, Head and Neck Cancer

This research study is evaluating a program that entails remote monitoring and home-based care for people with cancer who are receiving chemotherapy, radiotherapy, or chemoradiotherapy.

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Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

Conditions: Urothelial Carcinoma, Head and Neck, Gastric Cancer, Esophagogastric Junction Disorder, Nonsmall Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose urothelial, head and neck, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), esophageal or ovarian cancer that express the MAGE-A4 protein.

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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Conditions: Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma, Cervical Carcinoma, Colon Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Glioma, Head and Neck Carcinoma, Kidney Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Lung Carcinoma, Lymphoma, Malignant Uterine Neoplasm, Melanoma, Ovarian Carcinoma, Pancreatic Carcinoma, Plasma Cell Myeloma, Prostate Carcinoma, Rectal Carcinoma, Recurrent Bladder Carcinoma, Recurrent Breast Carcinoma, Recurrent Cervical Carcinoma, Recurrent Colon Carcinoma, Recurrent Colorectal Carcinoma, Recurrent Esophageal Carcinoma, Recurrent Gastric Carcinoma, Recurrent Glioma, Recurrent Head and Neck Carcinoma, Recurrent Liver Carcinoma, Recurrent Lung Carcinoma, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Melanoma, Recurrent Ovarian Carcinoma, Recurrent Pancreatic Carcinoma, Recurrent Plasma Cell Myeloma, Recurrent Prostate Carcinoma, Recurrent Rectal Carcinoma, Recurrent Skin Carcinoma, Recurrent Thyroid Gland Carcinoma, Recurrent Uterine Corpus Carcinoma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Plasma Cell Myeloma, Skin Carcinoma, Thyroid Gland Carcinoma, Uterine Corpus Cancer

This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients’ tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor’s particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

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TCR-engineered T Cells in Solid Tumors (AC Tenguine IMA201-101) (ACTengine)

Conditions: Solid Tumor, Cancer, Recurrent Solid Tumors, Refractory Solid Tumors

The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).

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Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer

Conditions: Cancer of the Head and Neck, Oropharynx Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Throat Carcinoma

This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.

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Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer

Conditions: Advanced Bile Duct Carcinoma, Advanced Breast Carcinoma, Advanced Cervical Carcinoma, Advanced Endometrial Carcinoma, Advanced Esophageal Carcinoma, Advanced Gastric Carcinoma, Advanced Head and Neck Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma, Advanced Penile Carcinoma, Advanced Pleural Malignant Mesothelioma, Advanced Urothelial Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Pathologic Stage III Gastric Cancer AJCC v8, Pathologic Stage IIIA Gastric Cancer AJCC v8, Pathologic Stage IIIB Gastric Cancer AJCC v8, Pathologic Stage IIIC Gastric Cancer AJCC v8, Pathologic Stage IV Gastric Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage III Cervical Cancer AJCC v8, Stage III Distal Bile Duct Cancer AJCC v8, Stage III Intrahepatic Bile Duct Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Penile Cancer AJCC v8, Stage III Pleural Malignant Mesothelioma AJCC v8, Stage IIIA Cervical Cancer AJCC v8, Stage IIIA Distal Bile Duct Cancer AJCC v8, Stage IIIA Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA Penile Cancer AJCC v8, Stage IIIA Pleural Malignant Mesothelioma AJCC v8, Stage IIIA1 Ovarian Cancer AJCC v8, Stage IIIA2 Ovarian Cancer AJCC v8, Stage IIIB Cervical Cancer AJCC v8, Stage IIIB Distal Bile Duct Cancer AJCC v8, Stage IIIB Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIB Penile Cancer AJCC v8, Stage IIIB Pleural Malignant Mesothelioma AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IV Cervical Cancer AJCC v8, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Intrahepatic Bile Duct Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Stage IV Pleural Malignant Mesothelioma AJCC v8, Stage IVA Cervical Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVB Cervical Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Triple-Negative Breast Carcinoma, Unresectable Urothelial Carcinoma

Advanced Bile Duct Carcinoma, Advanced Breast Carcinoma, Advanced Cervical Carcinoma, Advanced Endometrial Carcinoma, Advanced Esophageal Carcinoma, Advanced Gastric Carcinoma, Advanced Head and Neck Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma, Advanced Penile Carcinoma, Advanced Pleural Malignant Mesothelioma, Advanced Urothelial Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Pathologic Stage III Gastric Cancer AJCC v8, Pathologic Stage IIIA Gastric Cancer AJCC v8, Pathologic Stage IIIB Gastric Cancer AJCC v8, Pathologic Stage IIIC Gastric Cancer AJCC v8, Pathologic Stage IV Gastric Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage III Cervical Cancer AJCC v8, Stage III Distal Bile Duct Cancer AJCC v8, Stage III Intrahepatic Bile Duct Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Penile Cancer AJCC v8, Stage III Pleural Malignant Mesothelioma AJCC v8, Stage IIIA Cervical Cancer AJCC v8, Stage IIIA Distal Bile Duct Cancer AJCC v8, Stage IIIA Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA Penile Cancer AJCC v8, Stage IIIA Pleural Malignant Mesothelioma AJCC v8, Stage IIIA1 Ovarian Cancer AJCC v8, Stage IIIA2 Ovarian Cancer AJCC v8, Stage IIIB Cervical Cancer AJCC v8, Stage IIIB Distal Bile Duct Cancer AJCC v8, Stage IIIB Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIB Penile Cancer AJCC v8, Stage IIIB Pleural Malignant Mesothelioma AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IV Cervical Cancer AJCC v8, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Intrahepatic Bile Duct Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Stage IV Pleural Malignant Mesothelioma AJCC v8, Stage IVA Cervical Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVB Cervical Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Triple-Negative Breast Carcinoma, Unresectable Urothelial Carcinoma

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Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

Conditions: Advanced Differentiated Thyroid Gland Carcinoma, Advanced Head and Neck Carcinoma, Advanced Hepatocellular Carcinoma, Advanced Kaposi Sarcoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma, Advanced Ovarian Carcinoma, Advanced Prostate Carcinoma, Advanced Renal Cell Carcinoma, Advanced Thyroid Gland Medullary Carcinoma, Advanced Urothelial Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, HIV Infection, Metastatic Differentiated Thyroid Gland Carcinoma, Metastatic Head and Neck Carcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Kaposi Sarcoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Ovarian Carcinoma, Metastatic Prostate Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Thyroid Gland Medullary Carcinoma, Metastatic Triple-Negative Breast Carcinoma, Metastatic Urothelial Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Recurrent Differentiated Thyroid Gland Carcinoma, Recurrent Head and Neck Carcinoma, Recurrent Hepatocellular Carcinoma, Recurrent Kaposi Sarcoma, Recurrent Lung Non-Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Recurrent Malignant Solid Neoplasm, Recurrent Melanoma, Recurrent Ovarian Carcinoma, Recurrent Prostate Carcinoma, Recurrent Renal Cell Carcinoma, Recurrent Thyroid Gland Medullary Carcinoma, Recurrent Triple-Negative Breast Carcinoma, Recurrent Urothelial Carcinoma, Refractory Differentiated Thyroid Gland Carcinoma, Stage III Differentiated Thyroid Gland Carcinoma AJCC v8, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage III Thyroid Gland Medullary Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIA1 Ovarian Cancer AJCC v8, Stage IIIA2 Ovarian Cancer AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Stage IV Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8, Triple-Negative Breast Carcinoma

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that has spread to other places in the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.

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The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial

Conditions: Neoplasm, Skull Base Neoplasm

This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic acid (5-ALA) is a safe and effective FDA-approved agent successfully used by neurosurgeons for FGS of different brain tumors is given to the patients preoperatively. Using specific wavelengths of light as well as specialized magnified lenses the surgeons use this technique to assist in tumor resection.

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Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord

Conditions: Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma, Metastatic Kidney Carcinoma, Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Neoplasm of Unknown Primary, Metastatic Melanoma, Prostate Carcinoma Metastatic in the Bone, Sarcoma, Solid Neoplasm, Spinal Cord Compression, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Lung Non-Small Cell Cancer AJCC v7, Thyroid Gland Carcinoma

This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.

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Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer

Conditions: Malignant Melanoma, Head and Neck Cancer

The overall goal of this study is to develop a pre-clinical platform of melanoma and head and neck squamous cell cancer that will allow the investigators to learn more about these diseases and discover better and more individualized treatments.

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TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy

Conditions: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Renal Cell Carcinoma, Small-cell Lung Cancer, Cutaneous Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma, Merkel Cell Carcinoma

TiTAN-1 is a first-in-human study of GEN-011, an experimental treatment being evaluated in adult patients with advanced cancer. GEN-011 is a T cell therapy made specific to each patient, using the patient’s own circulating immune cells. First, Genocea confirms which cancer proteins are recognized already by each patient’s T cells using ATLAS™. Then, immune cells that recognize these cancer proteins are multiplied many times (a process called PLANET™) to create a personalized GEN-011 cell therapy, which is given back to the patient in one or more intravenous (IV) infusions.

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TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers

Conditions: Hepatocellular Carcinoma, Metastatic Castration Resistant Prostate Cancer, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Squamous Cell Carcinoma of Head and Neck, Triple-Negative Breast Cancer, Urothelial Carcinoma, Cholangiocarcinoma, GastroEsophageal Cancer, Pancreatic Cancer, Sarcoma

This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.

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Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer

Conditions: Malignant Neoplasms of Respiratory and Intrathoracic Organs, Squamous Cell Carcinoma of the Larynx

The goal of this clinical research study is to find the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients with laryngeal cancer. The safety of this radiation will also be studied.

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TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers

Conditions: Cancer

“TTX-080-01 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor) or cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies.


The study is enrolling in the dose expansion cohorts.”

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Vaccination With Flt3L, Radiation, and Poly-ICLC

Conditions: Non-Hodgkin’s Lymphoma, Metastatic Breast Cancer, Head and Neck Squamous Cell Carcinoma

This is a combination of 4 therapies, three of which are used to treat a single “target site” of your cancer (such as a lymph node or a single tumor), and the 4th is given directly into the blood stream (intravenous or “IV”).

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X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma

Conditions: Advanced Cancer

In this Phase I trial for subjects with advanced head & neck cancer, breast cancer, soft tissue sarcoma or melanoma all subjects will receive open label X-PACT treatment as a intra-tumoral injection. The primary objective will be to establish the safety of X-PACT when dosed with 5 intra-tumoral injections of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) over a period of 6 weeks (on day D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6). After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart. Treatment will be considered safe provided ≤ 2 out of 12 patients experience a dose-limiting toxicity (DLT) during the 6 weeks after the first intra-tumoral injection.

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1-866-792-4622 (HNCA)




As a decade-long survivor of stage IV tongue cancer and Founder of WesternOhio Oral, Head and Neck Cancer Support, Hank refers to head and neck cancer as an “orphan” cancer: "Very little is known about head and neck cancer, and comparatively, it receives less attention than other cancers. HNCA is working to change this."Hank Deneski
Survivor of Stage IV tongue cancer and Founder of WesternOhio Oral, Head and Neck Cancer Support


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