OncoMatch/Clinical Trials/NCT04747054
Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers
Official title: Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Alone or With Chemotherapy Versus Systemic Treatment Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases
Is NCT04747054 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including Pembrolizumab and Chemotherapy for squamous cell carcinoma of head and neck.
Treatment: Pembrolizumab · Chemotherapy — Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
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.
Frequently asked questions
Is NCT04747054 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy, non-surgical treatment for invasive head and neck cancer disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 cps ≥1 is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1-4 or N0-3 is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify