OncoMatch/Clinical Trials/NCT04747054

Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers

Is NCT04747054 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Pembrolizumab and Chemotherapy for squamous cell carcinoma of head and neck.

Phase 3RecruitingUNICANCERNCT04747054Data as of May 2026

Treatment: Pembrolizumab · Chemotherapy — Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) cps ≥1 (cps ≥1)

Disease stage

Required: Stage T1-4, N0-3

Metastatic disease required

distant metastases at presentation (T1-4 N0-3 M1)

Performance status

WHO 0–1

Prior therapy

Cannot have received: radiotherapy

Prior radiotherapy in the head and neck region

Cannot have received: non-surgical treatment for invasive head and neck cancer

Exception: except for pembrolizumab +/- chemotherapy for the current cancer for a maximum of 6 cycles; prior surgical treatment alone in the head and neck region could be eligible

Any prior or current non-surgical treatment for invasive head and neck cancer. (except for pembrolizumab +/- chemotherapy for the current cancer for a maximum of 6 cycles). This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, chemotherapy, anti-PD-1/PD-L1 and CTLA-4, prior radiotherapy (RT), or use of any investigational agent. Loco-regional recurrent or second primary head and neck cancer after prior surgical treatment alone in the head and neck region could be eligible.

Lab requirements

Blood counts

Absolute neutrophil count ≥1.5 × 10⁹/L (≥1.0 × 10⁹/L if randomization after treatment start); Platelet ≥100 × 10⁹/L (≥75 × 10⁹/L if randomization after treatment start); Hemoglobin ≥90 g/L (≥85 g/L if randomization after treatment start)

Kidney function

Creatinine clearance ≥30 mL/min (calculated per institutional guidelines or by Cockcroft-Gault or MDRD formula)

Liver function

AST and ALT ≤3 × ULN (≤5 × ULN if liver metastases); Bilirubin ≤1.5 × ULN; Serum albumin ≥25 g/L

Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization: ... see full text

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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