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

Korábbi kezelés

• 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
• 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

Más betegség

• 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)
• History of allergy or hypersensitivity to study drug components

Laborértékek

• Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation

• 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