Phase 1 Study of Pembrolizumab with Radiation and Salvage Surgery for Persistent or Recurrent Head and Neck Squamous Cell Cancer

What this Trial Is About

Researchers are evaluating the possible side effects and clinical benefits of combining pembrolizumab immunotherapy with radiation therapy and surgery in patients with persistent or recurrent head and neck squamous cell cancer. This phase I trial focuses on patients whose cancer remains or has returned despite previous treatment. The study aims to understand how radiation doses affect immune response and tumor behavior, and to assess safety, survival, and quality of life measures. Participants are assigned to one of three treatment groups. All receive pembrolizumab intravenously starting in week 1, followed by surgery and intraoperative radiation therapy IORT at different times depending on the group. Some groups also receive external beam radiation therapy EBRT at low or high doses before surgery. Pembrolizumab treatment continues every three weeks for up to 18 doses after surgery, with the option to continue if tolerated and beneficial. During the study, participants undergo tumor tissue and blood sample collection for biomarker analysis. Researchers monitor tumor control, survival, immune markers, and quality of life for up to five years. Follow-up visits occur at 90 and 180 days post-treatment, then every 90 days up to two years, and every six months up to five years. The study measures adverse events and overall patient health throughout this period.

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer