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

Recruiting now · Phase 1/Phase 2

Conditions studied: Head and Neck Cancer, Recurrent Head and Neck Squamous Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT07213934

Run by

University of Cincinnati

People needed

40

Starts

2025-10-08

Expected to finish

2031-12-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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