ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localized Renal Cell Carcinoma (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 : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether the combination of nivolumab and ipilimumab is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced the partial or entire removal of a kidney

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Nivolumab Biological: Ipilimumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination 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 : September 5, 2022
Estimated Study Completion Date : July 7, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Module A: Nivolumab + Ipilimumab Biological: Nivolumab
Specified dose on specified days for 24 weeks
Other Name: Opdivo

Biological: Ipilimumab
Specified dose on specified days for 24 weeks
Other Name: Yervoy

Placebo Comparator: Module B: Placebo Drug: Placebo
Specified dose on specified days for 24 weeks




Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: Up to 5 years ]
    Per Blinded Independent Central Review (BICR)


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Defined as the time between the date of randomization and the date of death

  2. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years ]
    Safety and Tolerability



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.


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

Inclusion Criteria:

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

  • Kidney tumor has been completely resected 4 to 12 weeks prior to randomization
  • 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

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)
  • Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
  • Participants with a condition requiring systemic treatment with corticosteroids

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
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 #.

  Show 157 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03138512     History of Changes
Other Study ID Numbers: CA209-914
2016-004502-34 ( EudraCT Number )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs