Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)
Actual Study Start Date: March 12, 2015
Estimated Primary Completion Date: November 29, 2018
Estimated Study Completion Date: November 26, 2019

Arm:
- Experimental: Ipilimumab and Placebo matching Nivolumab
- Experimental: Nivolumab and Placebo matching Ipilimumab