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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04149574
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019
Date last updated
19/04/2024

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:
Urinary Bladder Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - nivolumab
Other interventions - Placebo
Treatment: Other - Bacillus Calmette-Guérin (BCG)

Experimental: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG) -

Placebo comparator: Arm B: placebo +BCG -


Treatment: Drugs: nivolumab
Specified Dose on Specified Days

Other interventions: Placebo
Specified Dose on Specified Days

Treatment: Other: Bacillus Calmette-Guérin (BCG)
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
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 3 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
approximately 3 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 participants with laboratory abnormalities
Timepoint [5] 0 0
approximately 3 years
Secondary outcome [6] 0 0
Number of participants with laboratory changes from baseline
Timepoint [6] 0 0
approximately 3 years
Secondary outcome [7] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [7] 0 0
approximately 3 years
Secondary outcome [8] 0 0
Number of Deaths
Timepoint [8] 0 0
approximately 3 years

Eligibility
Key inclusion criteria
* 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)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2023
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - 0002 - Sydney
Recruitment hospital [2] 0 0
Local Institution - 0001 - Woolloongabba
Recruitment hospital [3] 0 0
Local Institution - 0114 - Bowral
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4012 - Woolloongabba
Recruitment postcode(s) [3] 0 0
2576 - Bowral
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
RIO Negro
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Austria
State/province [6] 0 0
Linz
Country [7] 0 0
Austria
State/province [7] 0 0
Salzburger
Country [8] 0 0
Austria
State/province [8] 0 0
Wels
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Brazil
State/province [10] 0 0
Minas Gerais
Country [11] 0 0
Brazil
State/province [11] 0 0
RIO Grande DO SUL
Country [12] 0 0
Brazil
State/province [12] 0 0
Santa Catarina
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio de Janeiro
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Chile
State/province [16] 0 0
Coquimbo
Country [17] 0 0
Chile
State/province [17] 0 0
Metropolitana
Country [18] 0 0
Chile
State/province [18] 0 0
Valparaiso
Country [19] 0 0
France
State/province [19] 0 0
Angers Cedex 10
Country [20] 0 0
France
State/province [20] 0 0
DIJON Cedex
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Marseille Cedex 05
Country [23] 0 0
France
State/province [23] 0 0
Paris Cedex 14
Country [24] 0 0
France
State/province [24] 0 0
Paris Cedex 18
Country [25] 0 0
France
State/province [25] 0 0
Strasbourg
Country [26] 0 0
France
State/province [26] 0 0
Villejuif
Country [27] 0 0
Germany
State/province [27] 0 0
Herne
Country [28] 0 0
Germany
State/province [28] 0 0
Jena
Country [29] 0 0
Germany
State/province [29] 0 0
Koeln
Country [30] 0 0
Germany
State/province [30] 0 0
Trier
Country [31] 0 0
Greece
State/province [31] 0 0
Haidari
Country [32] 0 0
Greece
State/province [32] 0 0
Thessaloniki
Country [33] 0 0
Israel
State/province [33] 0 0
Tel-Aviv
Country [34] 0 0
Israel
State/province [34] 0 0
Jerusalem
Country [35] 0 0
Israel
State/province [35] 0 0
Ramat-gan
Country [36] 0 0
Italy
State/province [36] 0 0
TO
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Modena
Country [39] 0 0
Italy
State/province [39] 0 0
Napoli
Country [40] 0 0
Italy
State/province [40] 0 0
Reggio Emilia
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Japan
State/province [42] 0 0
Aichi
Country [43] 0 0
Japan
State/province [43] 0 0
Aomori
Country [44] 0 0
Japan
State/province [44] 0 0
Hokkaido
Country [45] 0 0
Japan
State/province [45] 0 0
Hyogo
Country [46] 0 0
Japan
State/province [46] 0 0
Ibaraki
Country [47] 0 0
Japan
State/province [47] 0 0
Kanagawa
Country [48] 0 0
Japan
State/province [48] 0 0
Nagasaki
Country [49] 0 0
Japan
State/province [49] 0 0
Nara
Country [50] 0 0
Japan
State/province [50] 0 0
Niigata
Country [51] 0 0
Japan
State/province [51] 0 0
Okayama
Country [52] 0 0
Japan
State/province [52] 0 0
Osaka
Country [53] 0 0
Japan
State/province [53] 0 0
Shizuoka
Country [54] 0 0
Japan
State/province [54] 0 0
Tokyo
Country [55] 0 0
Japan
State/province [55] 0 0
Wakayama
Country [56] 0 0
Netherlands
State/province [56] 0 0
Arnhem
Country [57] 0 0
Netherlands
State/province [57] 0 0
Rotterdam
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Moscow
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Saint-Petersburg
Country [60] 0 0
Spain
State/province [60] 0 0
Navarra
Country [61] 0 0
Spain
State/province [61] 0 0
Badajoz
Country [62] 0 0
Spain
State/province [62] 0 0
Badalona-barcelona
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Sabadell
Country [65] 0 0
Spain
State/province [65] 0 0
Santander
Country [66] 0 0
Spain
State/province [66] 0 0
València
Country [67] 0 0
Sweden
State/province [67] 0 0
Norrkoping
Country [68] 0 0
Sweden
State/province [68] 0 0
Umea

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/study/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
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/NCT04149574