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

NCT06256588 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 864

Last updated 2025-09-25

No results posted yet for this 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)

Conditions

  • Neoplasms, Head and Neck

Interventions

DRUG

Dostarlimab

Dostarlimab will be administered as an intravenous (IV) infusion

DRUG

Placebo

Placebo will be administered as an IV infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2028-06-30
Completion
2029-10-26
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06256588 on ClinicalTrials.gov