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

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Renal Cell

In brief

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.

Key facts

Study ID

NCT03138512

Run by

Bristol-Myers Squibb

People needed

1641

Starts

2017-07-07

Expected to finish

2024-02-01

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 tumor, node, and metastasis (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 renal cell cancer (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 (PS) 0-1
• Women must agree to follow methods of contraception, if applicable

You may not qualify if…

• 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 co-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
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0056 — Springdale, Arkansas, United States
• Local Institution - 0186 — Los Angeles, California, United States
• Local Institution - 0180 — Los Angeles, California, United States
• Local Institution - 0002 — San Francisco, California, United States
• Local Institution - 0185 — Aurora, Colorado, United States
• Local Institution - 0016 — Athens, Georgia, United States
• Local Institution - 0005 — Chicago, Illinois, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution - 0006 — St Louis, Missouri, United States
• Local Institution - 0012 — Howell Township, New Jersey, United States
• Local Institution - 0007 — Buffalo, New York, United States
• Local Institution - 0181 — New York, New York, United States
• Local Institution - 0001 — New York, New York, United States
• Local Institution - 0008 — Columbus, Ohio, United States
• Local Institution - 0009 — Portland, Oregon, United States
• Local Institution - 0010 — Allentown, Pennsylvania, United States
• Local Institution - 0014 — Greenville, South Carolina, United States
• Local Institution - 0013 — Chattanooga, Tennessee, United States
• Local Institution - 0183 — Nashville, Tennessee, United States
• Local Institution - 0057 — Fairfax, Virginia, United States
• Local Institution - 0178 — Capital Federal, Buenos Aires, Argentina
• Local Institution - 0126 — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0203 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0095 — Mar del Plata, Buenos Aires, Argentina
• Local Institution - 0019 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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