Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A, Arm A: nivolumab + ipilimumab
  • Biological: nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
  • Biological: ipilimumab
    Specified dose on specified days
    Other names:
    • Yervoy
Placebo Comparator
Part A, Arm B: nivolumab placebo + ipilimumab placebo
  • Drug: nivolumab placebo
    Specified dose on specified days
  • Drug: ipilimumab placebo
    Specified dose on specified days
Experimental
Part B, Arm A: nivolumab + ipilimumab
  • Biological: nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
  • Biological: ipilimumab
    Specified dose on specified days
    Other names:
    • Yervoy
Placebo Comparator
Part B, Arm B: nivolumab placebo + ipilimumab placebo
  • Drug: nivolumab placebo
    Specified dose on specified days
  • Drug: ipilimumab placebo
    Specified dose on specified days
Experimental
Part B, Arm C: nivolumab + ipilimumab placebo
  • Biological: nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
  • Drug: ipilimumab placebo
    Specified dose on specified days

More Details

Status
Completed
Sponsor
Bristol-Myers Squibb

Study Contact

Detailed Description

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.