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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)

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ClinicalTrials.gov Identifier: NCT03138512
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 1, 2017
First Posted Date  ICMJE May 3, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE July 5, 2017
Estimated Primary Completion Date April 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
Disease-free survival (DFS) as assessed by BICR (Part A and Part B) [ Time Frame: Up to 10 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2017)
Disease-free survival (DFS) [ Time Frame: Up to 5 years ]
Per Blinded Independent Central Review (BICR)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • Overall Survival (OS) (Part A and Part B) [ Time Frame: Up to 10 years ]
  • Incidence of Adverse Events (AEs) (Part A and Part B) [ Time Frame: Up to 10 years ]
  • Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C) [ Time Frame: Up to 10 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2017)
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Defined as the time between the date of randomization and the date of death
  • Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years ]
    Safety and Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 patients who have experienced partial or entire removal of a kidney
Detailed Description The study has two primary endpoints. The first primary completion date is anticipated to be reached Aug 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Biological: nivolumab
    Specified dose on specified days
    Other Name: Opdivo
  • Biological: ipilimumab
    Specified dose on specified days
    Other Name: Yervoy
  • Drug: nivolumab placebo
    Specified dose on specified days
  • Drug: ipilimumab placebo
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Part A, Arm A: nivolumab + ipilimumab
    Interventions:
    • Biological: nivolumab
    • Biological: ipilimumab
  • Placebo Comparator: Part A, Arm B: nivolumab placebo + ipilimumab placebo
    Interventions:
    • Drug: nivolumab placebo
    • Drug: ipilimumab placebo
  • Experimental: Part B, Arm A: nivolumab + ipilimumab
    Interventions:
    • Biological: nivolumab
    • Biological: ipilimumab
    • Drug: ipilimumab placebo
  • Placebo Comparator: Part B, Arm B: nivolumab placebo + ipilimumab placebo
    Interventions:
    • Drug: nivolumab placebo
    • Drug: ipilimumab placebo
  • Experimental: Part B, Arm C: nivolumab + ipilimumab placebo
    Interventions:
    • Biological: nivolumab
    • Drug: nivolumab placebo
    • Drug: ipilimumab placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2020)
1600
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2017)
800
Estimated Study Completion Date  ICMJE July 1, 2024
Estimated Primary Completion Date April 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Kidney tumor has been completely resected with randomization occurring 4 to 12 weeks prior to nephrectomy
  • Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
  • Post-nephrectomy tumor shows 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 (0 - 1)
  • Women and men must agree to follow methods of contraception

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 con-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 could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Japan,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   France,   Germany,   Italy,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03138512
Other Study ID Numbers  ICMJE CA209-914
2016-004502-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP