CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 864 target
Drug / intervention
Dostarlimab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Newly diagnosed unresected locally advanced HNSCC of oral cavity, oropharynx, hypopharynx or larynx
  • ✓Completed cisplatin plus radiotherapy with curative intent
  • ✓No evidence of distant metastatic disease
  • ✓PD-L1 positive tumor status
Key exclusion· 16
  • ✕Prior radiation therapy, systemic therapy, targeted therapy, or surgery for head and neck cancer not part of CRT
  • ✕Induction chemotherapy
  • ✕CRT with components other than cisplatin and RT such as cetuximab or experimental agents
  • ✕Cancer outside oropharynx, larynx, hypopharynx or oral cavity such as nasopharyngeal or sinus

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06256588
NCT06256588Phase 3RecruitingHigh Momentum
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Feb 13, 2024·Updated May 26, 2026

In Brief

A Phase 3 clinical trial evaluating Dostarlimab and Placebo for Neoplasms, Head and Neck. Currently recruiting, targeting 864 participants across 277 sites in 31 countries.

Signals

Enrolling ahead of pace

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Head and Neck
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Arab Emirates, United Kingdom, United States
Collaborators--

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedFeb 13, 2024
Enrollment StartMar 21, 2024
Primary CompletionJun 30, 2028
Study CompletionOct 26, 2029
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 2.4 years agoPrimary completion in 2.0 years

Interventions

Dostarlimabdrug

Dostarlimab will be administered as an intravenous (IV) infusion

Placebodrug

Placebo will be administered as an IV infusion