NCT01927419

Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Unresectable Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab
DRUG	Ipilimumab
DRUG	Placebo	Matching nivolumab

Timeline

• Start date: 2013-08-23
• Primary completion: 2014-07-24
• Completion: 2021-02-26
• First posted: 2013-08-22
• Last updated: 2022-03-18
• Results posted: 2016-02-08

Locations

21 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study