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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03519256
Ethics application status
Date submitted
17/04/2018
Date registered
8/05/2018
Date last updated
17/11/2020

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:
Bladder Cancer 0 0
Bladder Tumors 0 0
Neoplasms, Bladder 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
Other interventions - Nivolumab
Other interventions - BCG
Treatment: Drugs - BMS-986205

Experimental: Nivolumab monotherapy -

Experimental: Nivolumab + BCG -

Experimental: Nivolumab + BMS-986205 -

Experimental: Nivolumab + BMS-986205 + BCG -


Other interventions: Nivolumab
Specified dose on specified day

Other interventions: BCG
Specified dose on specified day

Treatment: Drugs: BMS-986205
Specified dose on specified day

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC)
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
Duration of complete response (DOCR), per PRC, in CIS participants with CR
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Incidence of Adverse Events (AEs)
Timepoint [2] 0 0
Up to 15 months
Secondary outcome [3] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to 15 months
Secondary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Up to 15 months
Secondary outcome [5] 0 0
Incidence of deaths
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Incidence of laboratory abnormalities
Timepoint [6] 0 0
Up to 15 months

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- 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
Gender
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 could 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Kogarah
Recruitment hospital [3] 0 0
Local Institution - St Leonards
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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California
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Kansas
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Louisiana
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Michigan
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Minnesota
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Nebraska
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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RIO Negro
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Argentina
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Cordoba
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Argentina
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Mendoza
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Brazil
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Ceara
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Parana
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RIO Grande DO SUL
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Brazil
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SAN Paulo
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Brazil
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Santa Catarina
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SAO Paulo
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Rio De Janeiro
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Sao Paulo
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Zhejiang
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Modena
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Amsterdam
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Utrecht
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Omsk
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Santander
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Valencia
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Turkey
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Istanbul
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United Kingdom
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Devon
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United Kingdom
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Essex
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Greater London
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United Kingdom
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Hampshire
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Lancaster
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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

Ethics approval
Ethics application status

Summary
Brief summary
A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or
without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer
Trial website
https://clinicaltrials.gov/show/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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email
Fax 0 0
Email 0 0
ClinicalTrials@bms.com
Contact person for scientific queries

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