CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 142 enrolled
Drug / intervention
Nivolumab +2 moredrug
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.

Search/NCT01927419
NCT01927419Phase 2Completed
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Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Bristol-Myers Squibb·interventional·Posted Aug 22, 2013·Updated Mar 18, 2022

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 1 other intervention for Unresectable Melanoma and Metastatic Melanoma. Completed, enrolled 142 participants across 21 sites in 2 countries.

Detailed Summary

The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnresectable Melanoma, Metastatic Melanoma
CountriesFrance, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 22, 2013
Enrollment StartAug 23, 2013
Primary CompletionJul 24, 2014
Study CompletionFeb 26, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.9 years ago

Interventions

Nivolumabdrug

Ipilimumabdrug

Placebodrug

Matching nivolumab