Actively Recruiting
Phase 3 Study Comparing Dostarlimab to Placebo After Chemoradiation in Adults With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Led by GlaxoSmithKline · Updated on 2026-05-26
864
Participants Needed
277
Research Sites
69 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.
CONDITIONS
Brief Title
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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