Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.


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: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Estimated Enrollment: 915
Study Start Date: May 2013
Estimated Study Completion Date: October 2017
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab
- Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab
- Experimental: Arm C: Ipilimumab+Placebo for Nivolumab