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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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.
Frequently asked questions
Is NCT07026474 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy, chemotherapy, targeted therapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 combined positive score (CPS) ≥1 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.
Check if I qualify