A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of informed consent
Patient/legal authorized representative (LAR) must be able to provide informed consent.
For Cohort B, the patient's melanoma must have progressed on prior combination PD-1 + LAG-3 blockade
Note: Intervening lines of targeted therapy, chemotherapy, bispecific (e.g. IMCgp100) and cell-based therapies are permitted between last ICI-based therapy and the start of study therapy
Disqualifiers
Uveal melanoma
Untreated central nervous system (CNS) metastases or leptomeningeal involvement; patients with brain metastases definitively treated with surgery or stereotactic radiosurgery (SRS) are permitted
For Cohort A: Any prior anti-LAG-3 (e.g., relatlimab) or CTLA-4 (e.g., ipilimumab) directed therapy, unless it was given in the adjuvant or neoadjuvant setting and the last dose was given more than three months prior to disease recurrence
For Cohort B: Any prior CTLA-directed therapy (e.g., ipilimumab), unless it was given in the adjuvant or neoadjuvant setting and the last dose was given more than three months prior to disease recurrence
Trial design
Treatments tested in this trial
- Fianlimab
- Cemiplimab
- Ipilimumab
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov