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 (CheckMate 914)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Renal Cell

Treatments: Drug: nivolumab placebo; Biological: ipilimumab; Biological: nivolumab; Drug: ipilimumab placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03138512

CA209-914

2016-004502-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,641 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,641 participants in 5 patient groups, including a placebo group

Part A, Arm A: nivolumab + ipilimumab

Experimental group

Treatment:

Biological: ipilimumab

Biological: nivolumab

Part A, Arm B: nivolumab placebo + ipilimumab placebo

Placebo Comparator group

Treatment:

Drug: ipilimumab placebo

Drug: nivolumab placebo

Part B, Arm A: nivolumab + ipilimumab

Experimental group

Treatment:

Biological: ipilimumab

Biological: nivolumab

Part B, Arm B: nivolumab placebo + ipilimumab placebo

Placebo Comparator group

Treatment:

Drug: ipilimumab placebo

Drug: nivolumab placebo

Part B, Arm C: nivolumab + ipilimumab placebo

Experimental group

Treatment:

Drug: ipilimumab placebo

Biological: nivolumab