Memorial Sloan Kettering Cancer Center
The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.
Inclusion Criteria: * Age ≥ 18 years at the time of informed consent * Patient/legal authorized representative (LAR) must be able to provide informed consent. * Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III/IV or metastatic stage IV cutaneous or mucosal melanoma that has progressed on PD-1/PD-L1 therapy: o For Cohort A, the patient's melanoma must have progressed on prior PD-1 monotherapy * For Cohort B, the patient's melanoma must have progressed on prior combination PD-1 + LAG-3 blockade * Note: Intervening lines of targeted therapy…
Fianlimab IV given every three weeks
Cemiplimab IV given every three weeks
Ipilimumab will be give every 6 weeks continuously