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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02632409
Registration number
NCT02632409
Ethics application status
Date submitted
14/12/2015
Date registered
16/12/2015
Date last updated
8/01/2024
Titles & IDs
Public title
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
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Scientific 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)
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Secondary ID [1]
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2014-003626-40
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Secondary ID [2]
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CA209-274
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 274
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Various Advanced Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Placebo
Experimental: Nivolumab - Nivolumab dose as specified
Placebo Comparator: Placebo - Placebo dose as specified
Other interventions: Nivolumab
Other interventions: Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease Free Survival (DFS)
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Assessment method [1]
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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.
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Timepoint [1]
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approximately up to 48 months
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Primary outcome [2]
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Disease Free Survival (DFS) in PD-L1 Expression = 1% Population
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Assessment method [2]
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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.
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Timepoint [2]
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approximately up to 48 months
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Secondary outcome [1]
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Non-Urothelial Tract Recurrence Free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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up to 53 months
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Secondary outcome [2]
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Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression = 1% Population
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Assessment method [2]
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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.
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Timepoint [2]
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up to 53 months
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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the time from randomization to the date of death from any cause.
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Timepoint [3]
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on going
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Secondary outcome [4]
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Overall Survival in Participants With PD-L1 Expression = 1%
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Assessment method [4]
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the time from randomization to the date of death from any cause.
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Timepoint [4]
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on going
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Secondary outcome [5]
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Disease Specific Survival
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Assessment method [5]
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the time from randomization to the date of death due to disease (urothelial cancer).
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Timepoint [5]
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on going
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Secondary outcome [6]
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Disease Specific Survival in Participants With PD-L1 Expression = 1%
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Assessment method [6]
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the time from randomization to the date of death due to disease (urothelial cancer).
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Timepoint [6]
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on going
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/05/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
709
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0048 - Liverpool
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Local Institution - 0047 - St. Leonards
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Local Institution - 0046 - Waratah
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Local Institution - 0050 - Elizabeth Vale
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Local Institution - 0184 - Frankston
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Recruitment hospital [6]
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Local Institution - 0175 - Perth
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2065 - St. Leonards
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2298 - Waratah
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Recruitment postcode(s) [4]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment postcode(s) [6]
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6150 - Perth
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Recruitment outside Australia
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Sevilla
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Sweden
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Lund
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Switzerland
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Basel
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Switzerland
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Zuerich
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Country [132]
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
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Greater Manchester
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United Kingdom
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Midlothian
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United Kingdom
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Surrey
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United Kingdom
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Yorkshire
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Other collaborator category [1]
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Commercial sector/Industry
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Ono Pharmaceutical Co. Ltd
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02632409
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02632409
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