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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

Trial Status: Active

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.

Inclusion Criteria

  • Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
  • Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), 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
  • Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (0 - 1)
  • Women must agree to follow methods of contraception, if applicable

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)
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell con-stimulation or checkpoint pathways
  • Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
  • History of allergy or hypersensitivity to study drug components
  • Participants with a condition requiring systemic treatment with corticosteroids
  • Participants who have received a live/attenuated vaccine within 30 days of first treatment


Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Bashir Wyatt
Phone: 310-794-3448


University of Colorado Hospital
Status: ACTIVE


Northwestern University
Status: ACTIVE


Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

Roswell Park Cancer Institute
Status: ACTIVE
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE


Ohio State University Comprehensive Cancer Center
Status: ACTIVE


Vanderbilt University / Ingram Cancer Center
Status: ACTIVE


M D Anderson Cancer Center

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).

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-914
  • Secondary IDs NCI-2017-01295, 2016-004502-34
  • ID NCT03138512