Clinical Trial

Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma

Recruiting Phase 1/2
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Summary
The purpose of the Phase I study is to see if it is safe to use X-ray photon radiation (XRT) and proton radiation (PT) before surgery in patients with recurrent head and neck squamous cell carcinoma (rHNSCC). The purpose of the Phase II study is to see if using XRT or PT before immunotherapy (pembrolizumab) prior to surgery benefits patients with recurrent head and neck squamous cell carcinoma (rHNSCC).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-10-08; most recent amendment 2026-06-29.
Status change: Not Yet Recruiting → Recruiting 2026-04-11
Trial Details
NCT Number NCT07213934
Lead Sponsor University of Cincinnati
Conditions Head and Neck Cancer, Recurrent Head and Neck Squamous Cell Carcinoma
Enrollment 40 participants
Start Date 2025-10-08
Primary Completion 2030-12 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-01