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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)

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ClinicalTrials.gov Identifier: NCT02632409
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 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 : February 11, 2016
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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



Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    DFS defined as the time between the date of randomization and the date of first recurrence or death (of any cause) whichever occurs first.


Secondary Outcome Measures :
  1. Non-Urothelial track recurrence free survival (NUTRFS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    NUTRFS is defined as the time between the date of randomization and the date of first local non urothelial tract or distant recurrence or death (of any cause), whichever occurs first.

  2. Disease specific survival (DSS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    DSS is defined the time between the date of randomization and the date of death due to disease (urothelial cancer).

  3. Overall survival (OS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    OS is defined as the time between the date of randomization and the date of death (of any cause).



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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

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


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 194 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02632409     History of Changes
Other Study ID Numbers: CA209-274
2014-003626-40 ( EudraCT Number )
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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