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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.

Phase 3RecruitingGlaxoSmithKlineNCT06256588Data as of May 2026

Treatment: DostarlimabThe 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)

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Extracted 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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Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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