A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Conditions

• Neoplasms, Head and Neck

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dostarlimab — DRUG
  Dostarlimab will be administered as an intravenous (IV) infusion
• Placebo — DRUG
  Placebo will be administered as an IV infusion

Study Details

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)

Key Dates

Start date

Mar 21, 2024

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Oct 26, 2029

Study Design

Enrollment

864 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Dostarlimab
• Placebo Comparator: Arm B: Placebo

Primary Outcome Measure

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 5 years ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (36)

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