Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

Official Title

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

Summary:

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Trial Description

Primary Outcome:

• Recurrence-Free Survival (RFS)
• Number of other safety biomarkers

• Overall survival (OS)
• Number of Participants with Serious Adverse Events (SAEs)
• Number of Participants with Adverse Events (AEs)
• Distant Metastases-Free Survival (DMFS)
• Objective Response Rates (ORR)
• Outcomes on Next-Line therapies (Objective response rate [if applicable], Duration of treatment on next-line therapies, Progression-Free Survival 2)
• Incidence of change in Vital Signs
• Incidence of change in Electrocardiograms (ECGs)
• Incidence of change in biomarkers
• Incidence of change in clinical laboratory values

View this trial on ClinicalTrials.gov