Overview

A Study to Evaluate the Superiority of the Fianlimab and Cemiplimab Combination Compared to Pembrolizumab in Adult and Adolescent Patients With Completely Resected High-Risk Skin Cancer

Status:
Not yet recruiting

Trial end date:
2029-10-11

Target enrollment:

Participant gender:

Summary

The primary objective of the study is To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS) The secondary objectives of the study are: - To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) - To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS) - To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab - To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults - To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab - To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older - To assess immunogenicity of fianlimab and against cemiplimab

Phase:

Phase 3

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Treatments:

Cemiplimab
Pembrolizumab