Overview

Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Status:
Not yet recruiting

Trial end date:
2030-04-13

Target enrollment:

Participant gender:

Summary

The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: - To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) - To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab - To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component - To assess immunogenicity of fianlimab and cemiplimab - To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults - To characterize safety and tolerability of treatment in patients 12 to <18 years of age - To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age - To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab - To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years

Phase:

Phase 3

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Treatments:

Cemiplimab
Pembrolizumab