OncoMatch/Clinical Trials/NCT06256588
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Is NCT06256588 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Dostarlimab for neoplasms, head and neck.
Treatment: Dostarlimab — 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)
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PD-L1 (CD274) positive tumor status
PD-L1 positive tumor status
Required: CDKN2A p16 immunohistochemistry testing required
If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cisplatin plus radiotherapy (cisplatin) — CRT with curative intent
completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent
Cannot have received: radiation therapy, systemic therapy, targeted therapy, or surgery not considered part of CRT
Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT
Cannot have received: induction chemotherapy
Participants receiving induction chemotherapy are excluded
Cannot have received: CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) (cetuximab)
CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor [e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137]
Lab requirements
Blood counts
Kidney function
Liver function
Has adequate organ function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GSK Investigational Site · Jonesboro, Arkansas
- GSK Investigational Site · Los Angeles, California
- GSK Investigational Site · Solvang, California
- GSK Investigational Site · Stockton, California
- GSK Investigational Site · Torrance, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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