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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 patients who have experienced partial or entire removal of a kidney

Inclusion Criteria

  • Kidney tumor has been completely resected with randomization occurring 4 to 12 weeks prior to nephrectomy
  • 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
  • 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 and men must agree to follow methods of contraception

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

California

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

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

Buffalo
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

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

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
  • Clinicaltrials.gov ID NCT03138512