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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03519256




Registration number
NCT03519256
Ethics application status
Date submitted
17/04/2018
Date registered
8/05/2018
Date last updated
1/06/2023

Titles & IDs
Public title
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
Scientific title
A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
Secondary ID [1] 0 0
2017-003581-27
Secondary ID [2] 0 0
CA209-9UT
Universal Trial Number (UTN)
Trial acronym
CheckMate 9UT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - BCG
Treatment: Drugs - BMS-986205

Experimental: Nivolumab monotherapy -

Experimental: Nivolumab + BCG -

Experimental: Nivolumab + BMS-986205 -

Experimental: Nivolumab + BMS-986205 + BCG -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: BCG
Specified dose on specified days

Treatment: Drugs: BMS-986205
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment
Timepoint [3] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [4] 0 0
Number of Participants Immune-Mediated Adverse Events (IMAEs)
Timepoint [4] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [5] 0 0
Number of Participants Who Died
Timepoint [5] 0 0
From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)
Primary outcome [6] 0 0
Number of Participants With Specific Liver Laboratory Abnormalities
Timepoint [6] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [7] 0 0
Number of Participants With Specific Thyroid Laboratory Abnormalities
Timepoint [7] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [8] 0 0
Number of Participants With Changes From Baseline Laboratory Values
Timepoint [8] 0 0
From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [9] 0 0
Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status
Timepoint [9] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Primary outcome [10] 0 0
Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status
Timepoint [10] 0 0
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

Eligibility
Key inclusion criteria
* Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component
* Participants must have CIS to be eligible.
* Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Sign of locally advanced disease or metastatic bladder cancer
* Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
* Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/08/2022
Sample size
Target
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Local Institution - 0146 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0148 - St Leonards
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Distrito Federal
Country [20] 0 0
Argentina
State/province [20] 0 0
RIO Negro
Country [21] 0 0
Argentina
State/province [21] 0 0
Cordoba
Country [22] 0 0
Argentina
State/province [22] 0 0
Mendoza
Country [23] 0 0
Brazil
State/province [23] 0 0
Ceara
Country [24] 0 0
Brazil
State/province [24] 0 0
Parana
Country [25] 0 0
Brazil
State/province [25] 0 0
RIO Grande DO SUL
Country [26] 0 0
Brazil
State/province [26] 0 0
Santa Catarina
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio de Janeiro
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Chile
State/province [31] 0 0
Metropolitana
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Chongqing
Country [34] 0 0
China
State/province [34] 0 0
Fujian
Country [35] 0 0
China
State/province [35] 0 0
Guangdong
Country [36] 0 0
China
State/province [36] 0 0
Jiangsu
Country [37] 0 0
China
State/province [37] 0 0
Jiangxi
Country [38] 0 0
China
State/province [38] 0 0
Shandong
Country [39] 0 0
China
State/province [39] 0 0
Shanghai
Country [40] 0 0
China
State/province [40] 0 0
Sichuan
Country [41] 0 0
China
State/province [41] 0 0
Tianjin
Country [42] 0 0
China
State/province [42] 0 0
Zhejiang
Country [43] 0 0
France
State/province [43] 0 0
Hauts-de-Seine
Country [44] 0 0
France
State/province [44] 0 0
Maine-et-Loire
Country [45] 0 0
France
State/province [45] 0 0
Bordeaux Cedex
Country [46] 0 0
France
State/province [46] 0 0
Lille
Country [47] 0 0
France
State/province [47] 0 0
Strasbourg
Country [48] 0 0
Hong Kong
State/province [48] 0 0
Hong Kong
Country [49] 0 0
Italy
State/province [49] 0 0
Milano
Country [50] 0 0
Italy
State/province [50] 0 0
Napoli
Country [51] 0 0
Italy
State/province [51] 0 0
Pisa
Country [52] 0 0
Mexico
State/province [52] 0 0
Chiapas
Country [53] 0 0
Mexico
State/province [53] 0 0
Distrito Federal
Country [54] 0 0
Netherlands
State/province [54] 0 0
Amsterdam
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Netherlands
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Nijmegen
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Netherlands
State/province [56] 0 0
Utrecht
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Russian Federation
State/province [57] 0 0
Omsk
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Russian Federation
State/province [58] 0 0
Saint-Petersburg
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
Spain
State/province [60] 0 0
Malaga
Country [61] 0 0
Spain
State/province [61] 0 0
Santander
Country [62] 0 0
Spain
State/province [62] 0 0
Valencia
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Essex
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Greater London
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Hampshire
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Lancaster

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
Trial website
https://clinicaltrials.gov/study/NCT03519256
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03519256