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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138512
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Biological: nivolumab Biological: ipilimumab Drug: nivolumab placebo Drug: ipilimumab placebo Phase 3

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1641 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : July 3, 2024
Estimated Study Completion Date : August 23, 2032

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A, Arm A: nivolumab + ipilimumab Biological: nivolumab
Specified dose on specified days
Other Name: Opdivo

Biological: ipilimumab
Specified dose on specified days
Other Name: 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 Name: Opdivo

Biological: ipilimumab
Specified dose on specified days
Other Name: 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 Name: Opdivo

Drug: ipilimumab placebo
Specified dose on specified days


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

Secondary Outcome Measures :
  1. Overall Survival (OS) (Part A and Part B) [ Time Frame: Up to 10 years ]
  2. Incidence of Adverse Events (AEs) (Part A and Part B) [ Time Frame: Up to 100 days after the last dose of study treatment ]
  3. Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C) [ Time Frame: Up to 10 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138512


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03138512    
Other Study ID Numbers: CA209-914
2016-004502-34 ( EudraCT Number )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
localized
resected
adjuvant
Renal Cell Carcinoma
 Kidney Cancer
Nephrectomy
Clear cell
High Risk of Relapse/Recurrence
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action