At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,844 enrolled
Drug / intervention
nivolumab +1 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 Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
In Brief
A Phase 3 clinical trial evaluating nivolumab and ipilimumab for Melanoma. Completed, enrolled 1,844 participants across 124 sites in 19 countries.
Detailed Summary
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustralia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Israel, Italy, New Zealand, Poland, Romania, Russia, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartApr 2017
Primary CompletionJun 2020
Study CompletionFeb 2021
TodayJul 2026
First PostedMar 1, 2017
Enrollment StartApr 11, 2017
Primary CompletionJun 12, 2020
Study CompletionFeb 2, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.3 years ago
Interventions
nivolumabbiological
Specified Dose on Specified Days
ipilimumabbiological
Specified Dose on Specified Days