West Cancer Center

HEAD AND NECK: LOCALLY ADVANCED: POST-CRT: PD-L1 +: JADE

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Title

GlaxoSmithKline 221530 Head and Neck post CRT

Study Title

Site Link

NCT06256588

Malignancy

Head and Neck cancer, oropharyngeal oropharynx cancer, oral cavity cancer, larynx laryngeal cancer, hypopharynx hypopharyngeal cancer

Stage

Stage 3

Disease Setting

Adjuvant, post radiation

Line Of Therapy

post-CRT

Investigational Agent

dostarlimab

Drug Class

anti PD-1

Gary Tian MD, PhD

Sponsor

Glaxo Smith Kline

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Has newly diagnosed unresected LA histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease.
ECOG PS 0-1
PD-L1 positive
Must not have received prior XRT, systemic therapy, targeted thyerapy, or radical surgery for management of head and neck cancer not considered part of CRT
No cirrhosis
No prior PD-1/PD-L1 or other immunotherapy

Objective

Primary
- EFS by central review
Secondary
- OS
- EFS per investigator
- Safety
- PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

squamous cell carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized