At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 387 enrolled
Drug / intervention
Nivolumab 3 mg/kg IV +4 morebiological
Likely dose
Nivolumab 3 mg/kg IVfrom 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.
Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
In Brief
A Phase 3 clinical trial evaluating Nivolumab 3 mg/kg IV, Ipilimumab 1 mg/kg IV, and 3 other interventions for Melanoma. Completed, enrolled 387 participants across 57 sites in 13 countries.
Detailed Summary
The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustralia, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionApr 2017
Study CompletionMay 2021
TodayJul 2026
First PostedMar 21, 2016
Enrollment StartApr 4, 2016
Primary CompletionApr 20, 2017
Study CompletionMay 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.3 years ago
Interventions
Nivolumab 3 mg/kg IVbiological
Followed by Nivolumab monotherapy
Ipilimumab 1 mg/kg IVbiological
Followed by Nivolumab monotherapy
Nivolumab 1 mg/kg IVbiological
Ipilimumab 3 mg/kg IVbiological
Nivolumab 6 mg/kg IVbiological
A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.