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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Secondary ID [1] 0 0
2014-003626-40
Secondary ID [2] 0 0
CA209-274
Universal Trial Number (UTN)
Trial acronym
CheckMate 274
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Various Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Nivolumab - Nivolumab dose as specified

Placebo comparator: Placebo - Placebo dose as specified
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS)
Timepoint [1] 0 0
approximately up to 48 months
Primary outcome [2] 0 0
Disease Free Survival (DFS) in PD-L1 Expression = 1% Population
Timepoint [2] 0 0
approximately up to 48 months
Secondary outcome [1] 0 0
Non-Urothelial Tract Recurrence Free Survival
Timepoint [1] 0 0
up to 53 months
Secondary outcome [2] 0 0
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression = 1% Population
Timepoint [2] 0 0
up to 53 months
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
on going
Secondary outcome [4] 0 0
Overall Survival in Participants With PD-L1 Expression = 1%
Timepoint [4] 0 0
on going
Secondary outcome [5] 0 0
Disease Specific Survival
Timepoint [5] 0 0
on going
Secondary outcome [6] 0 0
Disease Specific Survival in Participants With PD-L1 Expression = 1%
Timepoint [6] 0 0
on going

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2027
Actual
Sample size
Target
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0048 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0047 - St. Leonards
Recruitment hospital [3] 0 0
Local Institution - 0046 - Waratah
Recruitment hospital [4] 0 0
Local Institution - 0050 - Elizabeth Vale
Recruitment hospital [5] 0 0
Local Institution - 0184 - Frankston
Recruitment hospital [6] 0 0
Local Institution - 0175 - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
6150 - Perth
Recruitment outside Australia
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United States of America
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Alaska
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Illinois
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Indiana
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Michigan
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North Carolina
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Oregon
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Pennsylvania
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Jena
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Ramat Gan
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Taichung
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Taipei
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United Kingdom
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Greater Manchester
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Midlothian
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Surrey
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Yorkshire
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02632409