Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.

NCT Number	NCT07552558
Lead Sponsor	Washington University School of Medicine Collaborators: Bicara Therapeutics
Conditions	Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma
Enrollment	45 participants
Start Date	2026-09-30
Primary Completion	2028-11-30 (estimated)
Study Completion	2033-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-13