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
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease. * Has provided acceptable core or excisional biopsy obtained prior to CRT: * PD-L1 positive tumor status * If the primary tumor site is oropharyngeal carcinoma, the participant must have p…
Interventions
- DrugDostarlimab
Dostarlimab will be administered as an intravenous (IV) infusion
- DrugPlacebo
Placebo will be administered as an IV infusion
Locations (240)
- GSK Investigational SiteJonesboro, Arkansas
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteSolvang, California
- GSK Investigational SiteStockton, California
- GSK Investigational SiteTorrance, California
- GSK Investigational SiteFarmington, Connecticut