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A Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

A Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers

A Phase Ib Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers (PANTHEoN)

NCT04892875•Jennifer Choe

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the safety and tolerability of chemotherapy and radiation in combination with the investigational study drugs zimberelimab (AB122) and etrumadenant (AB928) in subjects with a locally advances head or neck cancer. The study will also ask how the study drugs change the following: * The microbiome that lives in the mouth and on the skin * Immune cells as they respond to a skin wound * Scarring (fibrosis) caused by radiation After completing a screening phase, subjects will be assigned to one of three cohorts: * Cohort 1: Subjects who will receive cisplatin, radiation and zimberelimab followed by zimberelimab only. * Cohort 2: Subjects who will receive cisplatin, radiation, zimberelimab and etrumadenant followed by zimberelimab and etrumadent. * Cohort 3: Subjects who will receive cisplatin and radiation followed by an observation period. All three cohorts will be followed for a 24 months following the conclusion of the chemoradiation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the criteria below apply.
•1. Age ≥ 18 years of age.
•2. Ability to understand and the willingness to sign a written informed consent document.
•3. ECOG Performance Status 0-2.
•4. Histologically confirmed head and neck squamous cell carcinoma of the oropharynx, larynx, hypopharynx, or pharynx.
•5. Satisfies eligibility criteria for treatment with concurrent cisplatin with radiation for the definitive treatment of head and neck squamous cell carcinomas. Eligibility criteria are as follows: HPV-negative Stage III-IVB or HPV-positive Stages II-III and select stage I patients as per PI discretion.
•6. Adequate organ and marrow function defined as the following:
•1. Neutrophils ≥ 1500/μL (in absence of growth factor support)
•2. Platelets ≥ 100 x 103/μL without transfusion
•3. Hemoglobin ≥ 9.0 g/dL
+7 more criteria

Exclusion Criteria

•Participants are excluded from the study if any of the criteria below apply.
•1. Prior treatment for head and neck squamous cell carcinoma including systemic therapies, local therapies or radiation.
•2. Major medical or other conditions that might affect the study assays: major surgery or trauma in the past 28 days, known current pregnancy, poorly controlled diabetes (repeated glucose \>250), history of or current clinically relevant coagulation abnormalities, as determined by the PI. Tracheostomy and feeding tube placement are permitted at any time.
•3. Known additional malignancy within the past 3 years (exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma-in-situ that have undergone curative therapy).
•5. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring systemic antibiotic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the Investigator or PI.
•6. History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent.
•7. Known infection with hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
•8. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
•9. Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment.
•10. Cohort 2 only: Inability to swallow medications.
+14 more criteria

Key Dates

Start Date

December 31, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

November 30, 2023

Conditions

Head and Neck CancerSquamous Cell Carcinoma of Head and NeckOral Cavity Squamous Cell CarcinomaOral Cavity CancerOropharynx CancerOropharynx Squamous Cell CarcinomaLarynx CancerPharynx CancerHypopharynx CancerHypopharynx Squamous Cell Carcinoma

Interventions

Zimberelimab

DRUG

Etrumadenant

DRUG

Cisplatin

DRUG

Radiation

RADIATION

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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RECRUITINGPHASE1/PHASE2

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

NCT06385080

Squamous Cell Carcinoma of Head and Neck

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

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