Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab for Advanced Melanoma Treatment in Patients Resistant to PD-1 Therapy

What this Trial Is About

Researchers are evaluating a combination treatment of fianlimab, cemiplimab, and ipilimumab for people with locally advanced or metastatic melanoma that cannot be removed surgically and has not responded to prior therapies blocking PD-1 or PD-L1. This phase 2 study aims to determine whether this combination is safe and causes only mild or few side effects in those with refractory melanoma. All participants will receive intravenous fianlimab and cemiplimab every three weeks without interruption. Ipilimumab will be given intravenously every six weeks continuously. Initially, fianlimab and cemiplimab are given together, followed by ipilimumab on the first day of each treatment cycle according to institutional practices. The study includes two groups based on the type of prior therapy patients received one group with progression after PD-1 monotherapy and another group after combined PD-1 and LAG-3 blockade. Participants will undergo regular assessments including measuring tumor response every six weeks to determine the treatment effect. Researchers will monitor safety and side effects throughout the study. Participants must have measurable disease and meet specific health criteria before enrollment. The total duration of participation will depend on individual response and ongoing treatment needs, with safety and disease progression being closely followed by the research team.

A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma