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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

NCT04892875 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-11-30

No results posted yet for this study

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.

Conditions

  • Head and Neck Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Oral Cavity Squamous Cell Carcinoma
  • Oral Cavity Cancer
  • Oropharynx Cancer
  • Oropharynx Squamous Cell Carcinoma
  • Larynx Cancer
  • Pharynx Cancer
  • Hypopharynx Cancer
  • Hypopharynx Squamous Cell Carcinoma

Interventions

DRUG

Zimberelimab

Zimberelimab will be administered at a dose of 360 mg IV on Day 1 of each 21-day cycle for up to 11 cycles.

DRUG

Etrumadenant

Etrumadenant will be administered at a dose of 150 mg by mouth once daily on days 1-21 of each 21-day cycle for up to 11 cycles.

DRUG

Cisplatin

Concurrent weekly cisplatin and radiation will be administered as part of the subject's standard of care. Cisplatin and radiation will be initiated on the same day and continue for up to 7.5 weeks.

RADIATION

Radiation

Concurrent weekly cisplatin and radiation will be administered as part of the subject's standard of care. Cisplatin and radiation will be initiated on the same day and continue for up to 7.5 weeks.

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    collaborator INDUSTRY

  • Jennifer Choe

    lead OTHER

Principal Investigators

  • Jennifer Choe, MD, PhD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892875 on ClinicalTrials.gov