At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 418 enrolled
Drug / intervention
BMS-936558 (Nivolumab) +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
In Brief
A Phase 3 clinical trial evaluating BMS-936558 (Nivolumab), Placebo matching BMS-936558 (Nivolumab), and 2 other interventions for Melanoma. Completed, enrolled 418 participants across 75 sites in 16 countries.
Detailed Summary
The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesArgentina, Australia, Canada, Chile, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Norway, Poland, Spain, Sweden
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartJan 2013
Primary CompletionJun 2014
Study CompletionMay 2021
TodayJul 2026
First PostedNov 6, 2012
Enrollment StartJan 18, 2013
Primary CompletionJun 24, 2014
Study CompletionMay 14, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.7 years ago
Interventions
BMS-936558 (Nivolumab)biological
Placebo matching BMS-936558 (Nivolumab)biological
Dacarbazinedrug
Placebo matching Dacarbazinedrug