NCT07026474

Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC

Randomized Phase III Trial of Sequential Re-Radiochemotherapy and Pembrolizumab Versus Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive HNSCC (CPS≥1)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
OTHER	radiotherapy	single doses of 1.8Gy up to a total dose of 55.8Gy to 63.0Gy
DRUG	Cisplatin	40mg/m² BSA weekly concomitant to re-irradiation
DRUG	Pembrolizumab	i.v., 200mg absolute, q3w
DRUG	cisplatin + 5-fluorouracil (5FU)	Cisplatin: 100mg/m² BSA d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w
DRUG	Alternative medications: carboplatin + 5-fluorouracil (5FU)	Carboplatin: AUC5 d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w
DRUG	Alternative medications: carboplatin	AUC2 weekly
DRUG	Pembrolizumab	i.v., 200mg absolute, q3w, starting within 8-14 days after completion of RCT

Timeline

• Start date: 2025-10-30
• Primary completion: 2032-12-01
• Completion: 2032-12-31
• First posted: 2025-06-18
• Last updated: 2026-03-02

Locations

18 sites across 1 country: Germany