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 (May 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 · Pembrolizumab — 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
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) combined positive score (CPS) ≥1 (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.
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: radiation therapy
Prior radio(chemo)therapy of the neck less than 6 months ago.
Cannot have received: chemotherapy
Prior chemotherapy or targeted small molecule therapy within 2 weeks or anti-cancer monoclonal antibody (mAb) within 4 weeks prior to trial day 1 or who has not recovered from AEs due to a previously administered agent.
Cannot have received: targeted therapy
Prior chemotherapy or targeted small molecule therapy within 2 weeks or anti-cancer monoclonal antibody (mAb) within 4 weeks prior to trial day 1 or who has not recovered from AEs due to a previously administered agent.
Cannot have received: anti-cancer monoclonal antibody
Prior chemotherapy or targeted small molecule therapy within 2 weeks or anti-cancer monoclonal antibody (mAb) within 4 weeks prior to trial day 1 or who has not recovered from AEs due to a previously administered agent.
Cannot have received: PD-1/PD-L1 antibody
Exception: allowed if >6 months since primary treatment of locally advanced HNSCC
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 mm3 or Neutrophils ≥ 1,500 per mm3; Platelet count > 100,000 per mm3.
Kidney function
Creatinine Clearance ≥ 40ml/min (calculated from serum creatinine using the Cockcroft-Gault formula).
Liver function
Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). 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 mm3 or Neutrophils ≥ 1,500 per mm3; Platelet count > 100,000 per mm3. Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). AST (SGOT) / ALT (SGPT) ≤ 2.5 x institutional ULN. Creatinine Clearance ≥ 40ml/min (calculated from serum creatinine using the Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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