Phase 2 Study Comparing Cemiplimab Alone or With Fianlimab for Adults With HPV-Positive Head and Neck Cancer After Treatment

What this Trial Is About

Researchers are evaluating whether combining cemiplimab with fianlimab improves outcomes over cemiplimab alone in adults with HPV-positive head and neck cancer who have detectable minimal residual disease after completing definitive treatment. The study aims to see if the combination better prevents cancer recurrence and to assess the safety and tolerability of the combination compared to cemiplimab alone. This is a randomized Phase II trial led by the University of Chicago. Participants will be randomly assigned to receive either cemiplimab alone or a combination of cemiplimab and fianlimab. These treatments involve monoclonal antibodies given for one year. The study uses a parallel design to compare these two groups. Throughout the year, participants will have regular follow-up visits to monitor treatment effects and side effects. During the study, participants will undergo assessments to measure disease progression, response to treatment, and clearance of circulating tumor HPV DNA. Researchers will monitor recurrence-free survival and patterns of disease recurrence for up to five years after enrollment. Safety and tolerability will also be closely followed. Participants are expected to provide informed consent, and their overall health and organ function will be evaluated to ensure eligibility.

A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment