At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 405 enrolled
Drug / intervention
BMS-936558 +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 Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy
In Brief
A Phase 3 clinical trial evaluating BMS-936558, Dacarbazine, and 2 other interventions for Unresectable or Metastatic Melanoma. Completed, enrolled 405 participants across 95 sites in 14 countries.
Detailed Summary
The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnresectable or Metastatic Melanoma
CountriesAustria, Belgium, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartDec 2012
Primary CompletionFeb 2016
Study CompletionDec 2020
TodayJul 2026
First PostedNov 6, 2012
Enrollment StartDec 21, 2012
Primary CompletionFeb 16, 2016
Study CompletionDec 29, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.7 years ago
Interventions
BMS-936558biological
Dacarbazinedrug
Carboplatindrug
Paclitaxeldrug