Phase 2 Study of Pembrolizumab with Chemotherapy Before Surgery and Pembrolizumab After Surgery in Patients with Resectable Recurrent or New Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining the immunotherapy drug pembrolizumab with chemotherapy before and after surgery for squamous cell carcinoma of the head and neck HNSCC. This Phase II, open-label study focuses on patients with resectable recurrent HNSCC or new HNSCC in areas previously treated with radiation. The study drug pembrolizumab is designed to help the immune system fight this type of cancer, though it is not yet approved for use before and after surgery in HNSCC. Participants receive two cycles of pembrolizumab combined with chemotherapy drugs cisplatin or carboplatin and docetaxel before surgery. Surgery to remove the tumor or affected lymph nodes occurs 3 to 6 weeks after the second cycle. After surgery, participants continue pembrolizumab treatment alone every 21 days for up to 15 cycles, lasting about one year. Optional biopsies may also be taken during disease recurrence. During the study, participants undergo screening for eligibility, biopsies, radiologic scans, blood tests, and treatment visits. Researchers will monitor the rate of major pathological response within 2 months, treatment-related toxicities, overall survival, disease-free survival, and radiological response before surgery. The entire participation period may last up to 5 years, with follow-up visits every six months to assess long-term outcomes and safety.

Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC