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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04149574




Registration number
NCT04149574
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019
Date last updated
23/11/2020

Titles & IDs
Public title
A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)
Scientific title
A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG
Secondary ID [1] 0 0
CA209-7G8
Universal Trial Number (UTN)
Trial acronym
CheckMate 7G8
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 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: Drugs - nivolumab
Other interventions - Placebo
Other interventions - Bacillus Calmette-Guérin (BCG)

Experimental: Arm A: nivolumab -

Placebo Comparator: Arm B: placebo +BCG -


Treatment: Drugs: nivolumab
Specified Dose on Specific Days

Other interventions: Placebo
Specified Dose on Specific Days

Other interventions: Bacillus Calmette-Guérin (BCG)
Intravesicular

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

Outcomes
Primary outcome [1] 0 0
Event Free Survival (EFS)
Timepoint [1] 0 0
approximately 3 years
Secondary outcome [1] 0 0
Worsening- Free Survival (WFS)
Timepoint [1] 0 0
approximately 7 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
approximately 10 years
Secondary outcome [3] 0 0
Complete Response Rate (CRR)
Timepoint [3] 0 0
approximately 3 years
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
approximately 3 years
Secondary outcome [5] 0 0
Number of laboratory abnormalities
Timepoint [5] 0 0
approximately 3 years
Secondary outcome [6] 0 0
Number of Laboratory changes from baseline
Timepoint [6] 0 0
approximately 3 years
Secondary outcome [7] 0 0
Incidence of Adverse Events (AEs)
Timepoint [7] 0 0
approximately 3 years
Secondary outcome [8] 0 0
Incidence of serious adverse Events (SAEs)
Timepoint [8] 0 0
approximately 3 years
Secondary outcome [9] 0 0
Incidence of adverse events leading to discontinuation
Timepoint [9] 0 0
approximately 3 years
Secondary outcome [10] 0 0
Incidence of immune-medicated adverse events (IMAEs)
Timepoint [10] 0 0
approximately 3 years
Secondary outcome [11] 0 0
Incidence of Deaths
Timepoint [11] 0 0
approximately 3 years

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

Inclusion:

- Predominant histologic component (> 50%) must be urothelial (transitional cell)
carcinoma

- Persistent or recurrent disease = 24 months of last BCG dose, but not classified as
BCG unresponsive

- Histologically confirmed persistent or recurrent high-risk non-muscle-invasive
urothelial carcinoma (UC)

- Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6
doses)

- Sufficient tissue for both biomarker analysis and central pathology review committee
(PRC) confirmation of diagnosis

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

- Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to
follow contraceptive requirements
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic
UC

- UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters)
within 24 months of enrollment

- UC and/or CIS in the prostatic urethra within 12 months of enrollment

- Prior surgery (other than transurethral resection of the bladder tumor
(TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic
chemotherapy or immunotherapy for bladder cancer or UC

Other 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
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,QLD
Recruitment hospital [1] 0 0
Local Institution - Kogarah
Recruitment hospital [2] 0 0
Local Institution - St Leonards
Recruitment hospital [3] 0 0
Local Institution - Sydney
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Bowral
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
4012 - Woolloongabba
Recruitment postcode(s) [5] 0 0
2576 - Bowral
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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New York
Country [9] 0 0
United States of America
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Texas
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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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Caba
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Argentina
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Cordoba
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Austria
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Linz
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Austria
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Salzburger
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Austria
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Wels
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Austria
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Wien
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Brazil
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Minas Gerais
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Brazil
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RIO Grande DO SUL
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Brazil
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Santa Catarina
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Brazil
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Rio de Janeiro
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Coquimbo
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Chile
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Metropolitana
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Chile
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Valparaiso
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France
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Angers Cedex 10
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France
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DIJON Cedex
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France
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Lille
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France
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Lyon Cedex 08
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France
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Nice
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France
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Paris Cedex 14
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France
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Paris Cedex 18
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France
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Strasbourg
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France
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Toulouse Cedex 9
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France
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Villejuif
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Germany
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Aachen
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Germany
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Herne
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Jena
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Germany
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Koeln
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Germany
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Trier
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Greece
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Chaidari
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Greece
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Cork
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Israel
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Jerusalem
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Israel
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Ramat-gan
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Israel
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Tel Aviv
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Roma
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Torino
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Arnhem
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Leiden
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Rotterdam
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Utrecht
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Singapore
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Singapore
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Spain
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Badajoz
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Badalona-barcelona
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Madrid
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Malaga
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Pamplona
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Sabadell
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Santander
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Valencia
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Sweden
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Norrkoping
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Sweden
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Umea
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United Kingdom
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Greater Manchester
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United Kingdom
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Lanarkshire
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United Kingdom
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Bebington
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United Kingdom
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Bournemouth
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United Kingdom
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Coventry
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United Kingdom
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Manchester
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United Kingdom
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Sheffield
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United Kingdom
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Stoke-on-Trent

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

Ethics approval
Ethics application status

Summary
Brief summary
A study comparing nivolumab and bacterial drugs given to help the body's immune system in the
bladder versus bacterial drugs alone in high risk bladder cancer participants.
Trial website
https://clinicaltrials.gov/show/NCT04149574
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
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04149574