A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants… (NCT03138512) | Clinical Trial Compass
CompletedPhase 3
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
United States1,641 participantsStarted 2017-07-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 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
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 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 conditio…
What they're measuring
1
Disease-Free Survival (DFS) by BICR - Treatment Part A and B
Timeframe: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)