Phase II Study of Adding Chemotherapy or Chemo-Immunotherapy Before Salvage Surgery and Radiation for PD-L1 Positive Recurrent or Persistent Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the addition of chemotherapy or chemo-immunotherapy to standard salvage surgery followed by radiation therapy and cisplatin treatment in patients with PD-L1 positive head and neck squamous cell carcinoma that has returned or persisted after previous improvement. This phase II trial focuses on patients with locally recurrent or persistent cancer that has spread to nearby tissues or lymph nodes. The study aims to compare event-free survival and other outcomes among different treatment approaches to see if adding chemotherapy or immunotherapy improves results over surgery alone. Participants are randomly assigned to one of three groups one group receives standard salvage surgery followed by radiation and cisplatin the second group receives chemotherapy with carboplatin and paclitaxel before surgery, then radiation and cisplatin the third group receives chemo-immunotherapy with carboplatin, paclitaxel, and cemiplimab before surgery, then radiation and cisplatin. Chemotherapy or chemo-immunotherapy is given in two 21-day cycles before surgery. Radiation therapy and cisplatin treatment start within eight weeks after surgery for patients with high-risk features. Throughout the study, participants undergo CT and PET scans and may provide blood samples. They are monitored for treatment response, survival, disease progression, and side effects including surgical complications and adverse events. Follow-up continues at 12 weeks post-radiation and then every few months for up to several years to assess long-term outcomes. The primary measure is event-free survival up to seven years from randomization.

Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer