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

Study acronym: RePaIr-HN
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 21 → 24 locationsv5
  2. Trial sites expanded: 18 → 21 locations
    • Eligibility criteria expanded, about 1 word
    v4
  3. Site details revised at 5 of 18 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 31, 2025 to Oct 30, 2025
    • Primary completion date: Dec 31, 2032 to Dec 2032
    • Site details revised at 18 of 18 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07026474
Lead Sponsor Universität des Saarlandes
Conditions
(from sponsor)		 Recurrent Head and Neck Squamous Cell Carcinoma
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov