Phase 2 Study of Ficerafusp Alfa Plus Pembrolizumab Before Surgery in High-Risk, Resectable PD-L1-Positive Squamous Cell Carcinoma of the Head and Neck

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab before surgery in people with resectable, high-risk, locally advanced, PD-L1-positive squamous cell carcinoma of the head and neck HNSCC. This phase 2, open-label trial focuses on this specific cancer type to better understand treatment responses prior to surgical removal of tumors. The trial is supported by Bicara Therapeutics and led by Dana-Farber Cancer Institute. Participants will receive two cycles of treatment over 42 days. In the first cycle, pembrolizumab is given on day 1, and ficerafusp alfa is administered on days 1, 8, and 15. The second cycle includes both drugs given on day 1. After completing these cycles, participants will undergo standard surgical removal of their tumors. Following surgery, they will have an end-of-treatment visit and will be monitored for up to two years. Throughout the study, participants attend clinic visits for screening, treatment, surgery, and follow-up. They will have blood and urine tests, tumor biopsies, and imaging scans such as CT, MRI, or PET to assess their condition. Researchers will measure treatment response at surgery, track event-free and overall survival every three months for two years, and evaluate safety and other health outcomes. Participants are closely monitored to understand how well the treatments work and their side effects over time.

Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC