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NCT04149574 Clinical Trial

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)

Urinary Bladder Neoplasms Clinical Trial

— CheckMate 7G8  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04149574
Other study ID # CA209-7G8
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 15, 2020
Est. completion date October 31, 2023

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Related Conditions & MeSH terms

Intervention

Drug:
• nivolumab
Specified Dose on Specified Days
Other:
• Placebo
Specified Dose on Specified Days
Biological:
• Bacillus Calmette-Guérin (BCG)
Specified Dose on Specified Days

Locations
Country Name City State
Argentina Local Institution - 0080 Buenos Aires
Argentina Local Institution - 0009 Caba Buenos Aires
Argentina Local Institution - 0088 Capital Federal Buenos Aires
Argentina Local Institution - 0016 Ciudad Autonoma Beunos Aires Buenos Aires
Argentina Local Institution - 0107 Cordoba
Argentina Local Institution - 0081 Mar Del Plata Buenos Aires
Argentina Local Institution - 0008 Viedma RIO Negro
Australia Local Institution - 0114 Bowral
Australia Local Institution - 0002 Sydney New South Wales
Australia Local Institution - 0001 Woolloongabba Queensland
Austria Local Institution - 0097 Linz
Austria Local Institution - 0104 Salzburger
Austria Local Institution - 0098 Wels
Austria Local Institution - 0099 Wien
Brazil Local Institution - 0047 Itajai Santa Catarina
Brazil Local Institution - 0048 Porto Alegre RIO Grande DO SUL
Brazil Local Institution - 0049 Rio de Janeiro
Brazil Local Institution - 0050 Uberlandia Minas Gerais
Canada Local Institution - 0037 Montreal Quebec
Canada Local Institution - 0038 Montreal Quebec
Canada Local Institution - 0012 Rimouski Quebec
Canada Local Institution - 0017 Toronto Ontario
Chile Local Institution - 0011 La Serena Coquimbo
Chile Local Institution - 0010 Recoleta Metropolitana
Chile Local Institution - 0072 Vina del Mar Valparaiso
France Local Institution - 0042 Angers Cedex 10
France Local Institution - 0106 DIJON Cedex
France Local Institution - 0045 Lille
France Local Institution - 0108 Marseille Cedex 05
France Local Institution - 0103 Paris Cedex 14
France Local Institution - 0111 Paris Cedex 18
France Local Institution - 0041 Strasbourg
France Local Institution - 0040 Villejuif
Germany Local Institution - 0094 Herne
Germany Local Institution - 0093 Jena
Germany Local Institution - 0105 Koeln
Germany Local Institution - 0095 Trier
Greece Local Institution - 0031 Haidari
Greece Local Institution - 0032 Thessaloniki
Israel Local Institution - 0073 Jerusalem
Israel Local Institution - 0074 Ramat-gan
Israel Local Institution - 0075 Tel Aviv Tel-Aviv
Italy Local Institution - 0062 Milano
Italy Local Institution - 0063 Modena
Italy Local Institution - 0064 Napoli
Italy Local Institution - 0065 Reggio Emilia
Italy Local Institution - 0066 Roma
Italy Local Institution - 0067 Torino TO
Japan Local Institution - 0162 Bunkyo-ku Tokyo
Japan Local Institution - 0159 Hamamatsu-shi Shizuoka
Japan Local Institution - 0157 Hirakata Osaka
Japan Local Institution - 0158 Hirosaki-shi Aomori
Japan Local Institution - 0151 Kashihara-shi Nara
Japan Local Institution - 0146 Kawasaki-shi Kanagawa
Japan Local Institution - 0155 Kobe-shi Hyogo
Japan Local Institution - 0156 Kurashiki-shi Okayama
Japan Local Institution - 0147 Nagakute-shi Aichi
Japan Local Institution - 0164 Nagasaki-shi Nagasaki
Japan Local Institution - 0165 Niigata-shi Niigata
Japan Local Institution - 0154 Osakasayamashi Osaka
Japan Local Institution - 0161 Sapporo-city Hokkaido
Japan Local Institution - 0150 Shinjuku-Ku Tokyo
Japan Local Institution - 0160 Takatsuki-shi Osaka
Japan Local Institution - 0149 Tsukuba-shi Ibaraki
Japan Local Institution - 0145 Wakayama
Japan Local Institution - 0153 Yokohama City Kanagawa
Netherlands Local Institution - 0054 Arnhem
Netherlands Local Institution Rotterdam
Russian Federation Local Institution - 0051 Moscow
Russian Federation Local Institution - 0052 Saint-Petersburg
Spain Local Institution - 0061 Badajoz
Spain Local Institution - 0060 Badalona-barcelona
Spain Local Institution - 0055 Madrid
Spain Local Institution - 0096 Pamplona Navarra
Spain Local Institution - 0059 Sabadell
Spain Local Institution - 0057 Santander
Spain Local Institution - 0058 València
Sweden Local Institution - 0087 Norrkoping
Sweden Local Institution - 0083 Umea
United States Local Institution - 0084 Bronx New York
United States The University Of Chicago Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Chile,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Netherlands,  Russian Federation,  Spain,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event Free Survival (EFS) approximately 3 years
Secondary Worsening- Free Survival (WFS) approximately 3 years
Secondary Overall Survival (OS) approximately 3 years
Secondary Complete Response Rate (CRR) approximately 3 years
Secondary Duration of Response (DOR) approximately 3 years
Secondary Number of participants with laboratory abnormalities approximately 3 years
Secondary Number of participants with laboratory changes from baseline approximately 3 years
Secondary Number of participants with Adverse Events (AEs) approximately 3 years
Secondary Number of Deaths approximately 3 years
See also
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Active, not recruiting NCT02805608 - uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer Phase 2
Not yet recruiting NCT02534623 - Postoperative Quality of Recovery After Transurethral Resection of the Bladder N/A
Recruiting NCT02228473 - Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort N/A
Completed NCT02778243 - Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level N/A
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT01688999 - Cabozantinib for Advanced Urothelial Cancer Phase 2
Completed NCT03219333 - A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer Phase 2
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Terminated NCT02560038 - Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer Phase 2
Not yet recruiting NCT02252445 - Propofol and Sevoflurane for Catheter-Related Bladder Discomfort N/A
Not yet recruiting NCT02760953 - TURBt With Adjuvant Cryoablation to Treat Bladder Cancer N/A
Terminated NCT04430036 - AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Phase 2
Active, not recruiting NCT06289283 - Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder
Active, not recruiting NCT03288545 - A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer Phase 1/Phase 2
Active, not recruiting NCT03661320 - A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer Phase 3
Completed NCT01478685 - A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors Phase 1
Completed NCT03404791 - A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy Phase 1
Terminated NCT01479348 - Imaging Study for FdCyd and THU Cancer Treatment Early Phase 1
Recruiting NCT05742867 - A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder

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