Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma (CheckMate 069)

The primary purpose of this study is to compare the objective response rate (ORR) as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in subjects with unresectable or metastatic melanoma


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Estimated Enrollment: 150
Study Start Date: August 2013
Estimated Study Completion Date: May 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Arm A: Nivolumab + Ipilimumab and Nivolumab
- Experimental: Arm B: Nivolumab-placebo + Ipilimumab and Nivolumab-placebo