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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT03138512
• Date of registration: 01/05/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: 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
• Scientific title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
• Date of first enrolment: July 7, 2017
• Target sample size: 1653
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03138512
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Romania, Russian Federation, Singapore, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Renal Cell

Intervention(s)

Biological: ipilimumab

Drug: nivolumab placebo

Biological: nivolumab

Drug: ipilimumab placebo

Primary Outcome(s)

Disease-free survival (DFS) as assessed by BICR (Part A and Part B) [Time Frame: Up to 10 years]

Secondary Outcome(s)

Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C) [Time Frame: Up to 10 years]

Incidence of Adverse Events (AEs) (Part A and Part B) [Time Frame: Up to 100 days after the last dose of study treatment]

Overall Survival (OS) (Part A and Part B) [Time Frame: Up to 10 years]

Secondary ID(s)

2016-004502-34

CA209-914

Source(s) of Monetary Support

Please refer to primary and secondary sponsors