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NCT06256588 · ClinicalTrials.gov registry record · Phase 3
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
A Phase 3 study of Neoplasms, Head and Neck, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 864
- Enrollment target
- 20
- Study locations
NCT06256588: Recruiting Phase 3 study of Neoplasms, Head and Neck, sponsored by GlaxoSmithKline.
NCT06256588 is a Phase 3 study of Neoplasms, Head and Neck that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 864 participants, above the 194-participant average among 4 other Neoplasms, Head and Neck trials with a reported enrollment target (345% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06256588, a Phase 3 study of Neoplasms, Head and Neck, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 864 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dostarlimab
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Solvang
- GSK Investigational Site - Stockton
- GSK Investigational Site - Torrance
Connecticut
- GSK Investigational Site - Farmington
- GSK Investigational Site - New Haven
Florida
- GSK Investigational Site - St. Petersburg
- GSK Investigational Site - Tamarac
Arkansas
- GSK Investigational Site - Jonesboro
District of Columbia
- GSK Investigational Site - Washington D.C.
Georgia
- GSK Investigational Site - Atlanta
Indiana
- GSK Investigational Site - Fort Wayne
Iowa
- GSK Investigational Site - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 864 participants |
| Start Date | 2024-03-21 |
| Est. Completion | 2029-10-26 |
| Phase | Phase 3 |
What NCT06256588 shows while recruiting
NCT06256588 is an interventional study that assigns participants to a tested intervention. The registered 864 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 4 other Neoplasms, Head and Neck trials with a reported enrollment target (345% higher).
The record links to 1 condition, with Neoplasms, Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06256588 names 20 study sites across 15 states, led by California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT06256588 about?
NCT06256588 is a clinical study titled "A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma". 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)
What is the current status of trial NCT06256588?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 864 participants. The study started on 2024-03-21. Estimated completion is 2029-10-26.
What conditions does trial NCT06256588 study?
This clinical trial studies the following conditions: Neoplasms, Head and Neck.
What interventions are being tested in trial NCT06256588?
The interventions under investigation include: Placebo (DRUG), Dostarlimab (DRUG).
Who is sponsoring clinical trial NCT06256588?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06256588 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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