A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

Official Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Summary:

The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Trial Description

Primary Outcome:

• Recurrence-Free Survival (RFS) time per Investigator assessment

• Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
• Overall Survival (OS)
• Incidence of Adverse Events (AEs)
• Severity of AEs
• Incidence of Serious Adverse Events (SAEs)
• Severity of SAEs
• Incidence of AEs leading to discontinuation (DC)
• Severity of AEs leading to DC
• Incidence of immune-mediated AEs (IMAEs)
• Severity of IMAEs
• Incidence of drug related AEs
• Severity of drug related AEs
• Incidence of deaths
• Incidence of clinically significant changes in clinical laboratory values: Hematology tests
• Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
• Duration of Treatment on next line therapies
• Progression-Free Survival 2 (PFS2)

View this trial on ClinicalTrials.gov