NCT03138512

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,641 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

Detailed description

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
BIOLOGICAL	nivolumab	Specified dose on specified days
BIOLOGICAL	ipilimumab	Specified dose on specified days
DRUG	nivolumab placebo	Specified dose on specified days
DRUG	ipilimumab placebo	Specified dose on specified days

Timeline

• Start date: 2017-07-07
• Primary completion: 2023-09-28
• Completion: 2024-02-01
• First posted: 2017-05-03
• Last updated: 2024-12-18
• Results posted: 2024-12-18

Locations

200 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Romania, Russia, Singapore, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study