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

Official Title

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

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 patients who have experienced partial or entire removal of a kidney

Trial Description

Primary Outcome:

• Disease-free survival (DFS) as assessed by BICR (Part A and Part B)

Secondary Outcome:

• Overall Survival (OS) (Part A and Part B)
• Incidence of Adverse Events (AEs) (Part A and Part B)
• Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)

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

View this trial on ClinicalTrials.gov