CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,641 enrolled
Drug / intervention
nivolumab +3 morebiological
Likely dose
Nivolumab and ipilimumab dosing specified but exact doses not provided in the available textAI-extracted
Key inclusion· 4
  • ✓Kidney tumor completely resected with negative margins; randomization >4 weeks to ≤12 weeks post-nephrectomy
  • ✓TNM staging: pT2a G3–G4, pT2b any grade, pT3 (a/b/c) any grade, pT4 any grade, or any T with N1 (all M0)
  • ✓Predominately clear cell RCC, including those with sarcomatoid features; no macroscopic residual disease or distant metastases
  • ✓ECOG Performance Status 0–1
Key exclusion· 6
  • ✕Active known or suspected autoimmune disease
  • ✕HIV-positive or AIDS history
  • ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other T-cell checkpoint pathway antibody/drug
  • ✕Condition requiring systemic corticosteroid treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03138512
NCT03138512Phase 3Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted May 3, 2017·Updated Dec 18, 2024

In Brief

A Phase 3 clinical trial evaluating nivolumab, ipilimumab, and 2 other interventions for Carcinoma, Renal Cell. Completed, enrolled 1,641 participants across 200 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 3, 2017
Enrollment StartJul 7, 2017
Primary CompletionSep 28, 2023
Study CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9.2 years ago

Interventions

nivolumabbiological

Specified dose on specified days

ipilimumabbiological

Specified dose on specified days

nivolumab placebodrug

Specified dose on specified days

ipilimumab placebodrug

Specified dose on specified days