NCT04892875

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)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jennifer Choe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-12-31
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-05-19
• Last updated: 2023-11-30

Regulatory

• FDA-regulated drug study