A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment

Official Title

A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

Summary:

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

Trial Description

Primary Outcome:

• Number of Participants with Adverse Events (AEs)
• Number of Participants with Serious Adverse Events (SAEs)
• Number of Participants With Adverse Events Including Dose Limiting Toxicity
• Number of Participants with AEs resulting in Discontinuation
• Number of Participants with AEs resulting in Death
• Number of Participants with AEs resulting in Laboratory Abnormalities
• Objective Response Rate (ORR)

• Duration of response (DOR)
• Median PFS
• Median Overall Survival (OS)
• Number of Participants with Anti-Drug Antibodies (ADA)-Positivity
• Progression Free Survival rates (PFS rates)
• Overall Survival Rates (OS rates)
• Objective Response Rate (ORR)

View this trial on ClinicalTrials.gov