Study of BMS-936558 vs. Dacarbazine in Untreated, Unresectable or Metastatic Melanoma (CheckMate 066)

The purpose of this study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated, unresectable or metastatic melanoma


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Estimated Enrollment: 410
Study Start Date: January 2013
Estimated Study Completion Date: November 2016
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Arm A: BMS-936558(Nivolumab) with Placebo matching Dacarbazine
- Active Comparator: Arm B: Dacarbazine with Placebo matching BMS-936558(Nivolumab)