Trials / Recruiting
RecruitingNCT06256588
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 864 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dostarlimab | Dostarlimab will be administered as an intravenous (IV) infusion |
| DRUG | Placebo | Placebo will be administered as an IV infusion |
Timeline
- Start date
- 2024-03-21
- Primary completion
- 2028-06-30
- Completion
- 2029-10-26
- First posted
- 2024-02-13
- Last updated
- 2025-09-25
Locations
240 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Norway, Poland, Portugal, Romania, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06256588. Inclusion in this directory is not an endorsement.