A Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localized Renal Cell Carcinoma

Status: Active

Description

The purpose of this study is to determine whether the combination of nivolumab and ipilimumab is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced the partial or entire removal of a kidney

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com - Kidney tumor has been completely resected 4 to 12 weeks prior to randomization - Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 - Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including participants with sarcomatoid features Exclusion Criteria: - Participants with an active known or suspected autoimmune disease - Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation - Participants with a condition requiring systemic treatment with corticosteroids Other protocol defined inclusion/exclusion criteria could apply

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: Bashir Wyatt
Phone: 310-794-3448
Email: BAWyatt@mednet.ucla.edu

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-914
Secondary IDs NCI-2017-01295, 2016-004502-34
Clinicaltrials.gov ID NCT03138512