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An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CheckMate 274)

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: NCT02632409
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Results First Posted : December 1, 2021
Last Update Posted : January 8, 2024
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Condition or disease Intervention/treatment Phase
Various Advanced Cancer Biological: Nivolumab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 709 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
Actual Study Start Date : March 22, 2016
Actual Primary Completion Date : July 17, 2020
Estimated Study Completion Date : May 27, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab dose as specified
 Biological: Nivolumab
Placebo Comparator: Placebo
Placebo dose as specified
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: approximately up to 48 months ]
    The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

  2. Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population [ Time Frame: approximately up to 48 months ]
    The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Non-Urothelial Tract Recurrence Free Survival [ Time Frame: up to 53 months ]
    The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

  2. Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population [ Time Frame: up to 53 months ]
    The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

  3. Overall Survival [ Time Frame: on going ]
    the time from randomization to the date of death from any cause.

  4. Overall Survival in Participants With PD-L1 Expression ≥ 1% [ Time Frame: on going ]
    the time from randomization to the date of death from any cause.

  5. Disease Specific Survival [ Time Frame: on going ]
    the time from randomization to the date of death due to disease (urothelial cancer).

  6. Disease Specific Survival in Participants With PD-L1 Expression ≥ 1% [ Time Frame: on going ]
    the time from randomization to the date of death due to disease (urothelial cancer).


Eligibility Criteria
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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 BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
  • Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
  • Must have disease free status as determined by imaging within 4 weeks of dosing
  • Tumor tissue must be provided for biomarker analysis
  • Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

  • Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
  • Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
  • Subjects with active, known or suspected autoimmune disease
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
  • Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
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): NCT02632409


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] October 18, 2019
Statistical Analysis Plan  [PDF] November 16, 2019

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: NCT02632409    
Other Study ID Numbers: CA209-274
2014-003626-40 ( EudraCT Number )
First Posted: December 16, 2015    Key Record Dates
Results First Posted: December 1, 2021
Last Update Posted: January 8, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action