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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
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 - 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
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.