A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Dostarlimab: Dostarlimab will be administered as an intravenous (IV) infusion
Placebo: Placebo will be administered as an IV infusion
Study 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)
Eligibility
Primary outcome measure(s)
- Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) — Up to approximately 5 years
Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed \>20 weeks after completion of Concomitant Chemoradiotherapy (CRT) when invasive cancer is present or Death from any cause.
Trial sites (277)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Jonesboro | Arkansas | Recruiting |
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | Solvang | California | Recruiting |
| GSK Investigational Site | Stockton | California | Recruiting |
| GSK Investigational Site | Torrance | California | Recruiting |
| GSK Investigational Site | Farmington | Connecticut | Recruiting |
| GSK Investigational Site | New Haven | Connecticut | Recruiting |
| GSK Investigational Site | Washington D.C. | District of Columbia | Recruiting |
| GSK Investigational Site | St. Petersburg | Florida | Recruiting |
| GSK Investigational Site | Tamarac | Florida | Withdrawn |
| GSK Investigational Site | Atlanta | Georgia | Recruiting |
| GSK Investigational Site | Fort Wayne | Indiana | Recruiting |
| GSK Investigational Site | Iowa City | Iowa | Recruiting |
| GSK Investigational Site | Lexington | Kentucky | Recruiting |
| GSK Investigational Site | Columbia | Maryland | Recruiting |
| GSK Investigational Site | Worcester | Massachusetts | Recruiting |
| GSK Investigational Site | St Louis | Missouri | Recruiting |
| GSK Investigational Site | Omaha | Nebraska | Recruiting |
| GSK Investigational Site | New York | New York | Completed |
| GSK Investigational Site | The Bronx | New York | Recruiting |
| GSK Investigational Site | Canton | Ohio | Recruiting |
| GSK Investigational Site | Cincinnati | Ohio | Completed |
| GSK Investigational Site | Tulsa | Oklahoma | Recruiting |
| GSK Investigational Site | Philadelphia | Pennsylvania | Recruiting |
| GSK Investigational Site | Pittsburgh | Pennsylvania | Recruiting |
| GSK Investigational Site | Charleston | South Carolina | Recruiting |
| GSK Investigational Site | Greenville | South Carolina | Completed |
| GSK Investigational Site | Chattanooga | Tennessee | Recruiting |
| GSK Investigational Site | Germantown | Tennessee | Recruiting |
| GSK Investigational Site | Nashville | Tennessee | Recruiting |
| GSK Investigational Site | Dallas | Texas | Recruiting |
| GSK Investigational Site | Fort Worth | Texas | Recruiting |
| GSK Investigational Site | San Antonio | Texas | Recruiting |
| GSK Investigational Site | Fredericksburg | Virginia | Recruiting |
| GSK Investigational Site | Wytheville | Virginia | Recruiting |
| GSK Investigational Site | Tacoma | Washington | Withdrawn |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aire | Argentina | Recruiting |
+ 237 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06256588 on ClinicalTrials.gov ↗ ← All trials in Italy