OncoMatch/Clinical Trials/NCT07026474
Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC
Is NCT07026474 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for recurrent head and neck squamous cell carcinoma.
Treatment: Cisplatin · Pembrolizumab · cisplatin + 5-fluorouracil (5FU) · Alternative medications: carboplatin + 5-fluorouracil (5FU) · Alternative medications: carboplatin — Prospective, open-label, randomized controlled phase III trail that aims to investigate whether Re-Radiochemotherapy (Re-RCT) and sequential immunotherapy with pembrolizumab improves overall survival compared to the standard treatment with pembrolizumab alone (± chemotherapy) in locoregionally recurrent PD-L1 positive (CPS≥1) HNSCC.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (CPS ≥1)
PD-L1 combined positive score (CPS) ≥1 according to local pathological PD-L1 assessment. A validated test must be used in an accredited laboratory.
Disease stage
Excluded: Stage CM1
Locoregionally recurrent or second primary HNSCC. Tumor is surgically not resectable or surgical resection bears great potential for relevant functional morbidity or patient refuses surgery. No distant metastases (cM0).
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy — neck
Prior radio(chemo)therapy of the neck (time interval ≥ 6 months).
Cannot have received: radio(chemo)therapy of the neck
Exception: if less than 6 months ago
Prior radio(chemo)therapy of the neck less than 6 months ago.
Cannot have received: PD-1/PD-L1 antibody in primary treatment of locally advanced HNSCC
Exception: if less than 6 months ago
Prior treatment with a PD-1/PD-L1 antibody in primary treatment of locally advanced HNSCC less than 6 months ago.
Lab requirements
Blood counts
Haemoglobin ≥ 9.0 g/dL; Leukocytes (WBC) ≥ 3,000 per mm^3 or Neutrophils ≥ 1,500 per mm^3; Platelet count > 100,000 per mm^3.
Kidney function
Creatinine Clearance ≥ 40ml/min (Cockcroft-Gault formula)
Liver function
Serum bilirubin ≤ 1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT) / ALT (SGPT) ≤ 2.5 x institutional ULN.
Adequate normal organ and marrow function as defined: Haemoglobin ≥ 9.0 g/dL; Leukocytes (WBC) ≥ 3,000 per mm^3 or Neutrophils ≥ 1,500 per mm^3; Platelet count > 100,000 per mm^3. Serum bilirubin ≤ 1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT) / ALT (SGPT) ≤ 2.5 x institutional ULN. Creatinine Clearance ≥ 40ml/min (Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07026474 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radio(chemo)therapy of the neck, PD-1/PD-L1 antibody in primary treatment of locally advanced HNSCC disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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