Title
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants with Unresectable or Metastatic Melanoma

Description
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Objective
Primary: To demonstrate superiority of Arm A (fianlimab + cemiplimab) compared to Arm B (Opdualag) as measured by ORR

Secondary:
1) To describe PFS in Arm A and Arm B
2) To describe OS in Arm A and Arm B
3) To describe the duration of response (DOR) in Arm A and Arm B
4) To describe the disease control rate (DCR) in Arm A and Arm B
5) To describe ORR and PFS by investigator assessment in Arm A and Arm B
6) To assess the safety and tolerability of Arm A and Arm B
7) To characterize the pharmacokinetics (PK) of fianlimab and cemiplimab in Arm A
8) To assess the immunogenicity of fianlimab and cemiplimab

Treatment This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag and approved for the treatment of melanoma in adults and children.

Key Eligibility Key Inclusion Criteria:

Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.

Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.

Measurable disease per RECIST version 1.1.

Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Adequate bone marrow, hepatic, and kidney function.

Applicable Disease Sites
Other

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital