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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138512
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma 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 Aug 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 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 5, 2017
Estimated Primary Completion Date : April 10, 2023
Estimated Study Completion Date : July 1, 2024


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

Drug: ipilimumab placebo
Specified dose on specified days

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: nivolumab placebo
Specified dose on specified days

Drug: ipilimumab placebo
Specified dose on specified days




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


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


Contacts
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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 #.

Locations
Show Show 210 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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: August 10, 2020
Last Verified: August 2020
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
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
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents