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

Phase 2

Terminated

• Conditions: Urinary Bladder Neoplasms
• Interventions: Biological: Nivolumab; Biological: BCG; Drug: BMS-986205

• Registration Number: NCT03519256
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-08
• Study Start: 2018-08-02
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-24
• Status Verified: 2023-05
• Results First Submitted: 2023-05-03
• Results First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Results First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• 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

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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 apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab monotherapy	Nivolumab	-
Nivolumab + BMS-986205	Nivolumab	-
Nivolumab + BMS-986205 + BCG	Nivolumab	-
Nivolumab + BCG	BCG	-
Nivolumab + BMS-986205 + BCG	BCG	-
Nivolumab + BCG	Nivolumab	-
Nivolumab + BMS-986205	BMS-986205	-
Nivolumab + BMS-986205 + BCG	BMS-986205	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Serious Adverse Events (SAEs)	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death; * Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe); * Requires inpatient hospitalization or causes prolongation of existing hospitalization.; SAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs leading to discontinuation are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants Who Died	From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)	Number of participants who died.
Number of Participants With Specific Liver Laboratory Abnormalities	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	On-treatment laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment.; ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal.
Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.; An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug.; An ADA-positive participant has at least one ADA positive-sample relative to baseline at any time after initiation of treatment An ADA-negative participant doesn't not have an ADA-positive sample after the initiation of treatment.
Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death; * Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe); * Requires inpatient hospitalization or causes prolongation of existing hospitalization.; An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug.; An ADA-positive participant has at least one ADA positive-sample relative to baseline at any time after initiation of treatment An ADA-negative participant doesn't not have an ADA-positive sample after the initiation of treatment.
Number of Participants Immune-Mediated Adverse Events (IMAEs)	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity IMAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Specific Thyroid Laboratory Abnormalities	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	On-treatment laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment.; TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Number of Participants With Changes From Baseline Laboratory Values	From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)	On-study laboratory parameters include hematology, chemistry, liver function, and renal function. On-study laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment. On-study lab parameters are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Trial Locations

Locations (84)

Local Institution - 0001; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0044; 🇺🇸 Los Angeles, California, United States

Local Institution - 0140; 🇺🇸 Houston, Texas, United States

Local Institution - 0146; 🇦🇺 Camperdown, New South Wales, Australia

Local Institution - 0086; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0093; 🇭🇰 Hong Kong, Hong Kong

Local Institution - 0055; 🇲🇽 Ciudad de Mexico, Distrito Federal, Mexico

Local Institution - 0153; 🇷🇺 Saint-Petersburg, Russian Federation

Local Institution - 0098; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0094; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0048; 🇺🇸 Houston, Texas, United States

Local Institution - 0073; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil

Wichita Urology Group; 🇺🇸 Wichita, Kansas, United States

Local Institution - 0087; 🇺🇸 San Francisco, California, United States

Urology San Antonio Research, Pa; 🇺🇸 San Antonio, Texas, United States

Local Institution - 0032; 🇺🇸 Minneapolis, Minnesota, United States

Local Institution - 0125; 🇺🇸 Tampa, Florida, United States

Local Institution - 0023; 🇺🇸 New Lenox, Illinois, United States

Local Institution - 0136; 🇪🇸 Valencia, Spain

Local Institution - 0033; 🇪🇸 Malaga, Spain

Local Institution - 0131; 🇨🇳 Beijing, Beijing, China

Local Institution - 0139; 🇪🇸 Santander, Spain

Local Institution - 0028; 🇫🇷 Angers, Maine-et-Loire, France

Local Institution - 0097; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0129; 🇨🇳 Chongqing, Chongqing, China

Local Institution - 0109; 🇨🇳 Nan Chang, Jiangxi, China

Local Institution - 0112; 🇨🇳 Jinan, Shandong, China

Local Institution - 0133; 🇨🇳 Tianjin, Tianjin, China

Local Institution - 0126; 🇨🇳 Hangzhou, Zhejiang, China

Local Institution - 0120; 🇨🇳 Chengdu, Sichuan, China

Local Institution - 0099; 🇨🇳 Beijing, Beijing, China

Local Institution - 0102; 🇨🇳 Nanjing, Jiangsu, China

Local Institution - 0111; 🇨🇳 Yantai, Shandong, China

Local Institution - 0116; 🇨🇳 Beijing, Beijing, China

Local Institution - 0154; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0004; 🇳🇱 Amsterdam, Netherlands

Instituto Nazionale Tumori Fondazione G. Pascale; 🇮🇹 Napoli, Italy

Local Institution - 0015; 🇬🇧 Lancaster, United Kingdom

Local Institution - 0013; 🇬🇧 Southampton, Hampshire, United Kingdom

Local Institution - 0117; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0081; 🇺🇸 Riverside, California, United States

Local Institution - 0056; 🇺🇸 Hapeville, Georgia, United States

Local Institution - 0051; 🇺🇸 New York, New York, United States

Local Institution - 0040; 🇺🇸 Omaha, Nebraska, United States

Local Institution - 0144; 🇺🇸 New Brunswick, New Jersey, United States

Local Institution - 0036; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

Local Institution - 0058; 🇺🇸 Columbus, Ohio, United States

Local Institution - 0049; 🇺🇸 Charleston, South Carolina, United States

Urology Clinics Of North Texas, Pa; 🇺🇸 Dallas, Texas, United States

Local Institution - 0047; 🇺🇸 Lubbock, Texas, United States

Local Institution - 0141; 🇺🇸 Seattle, Washington, United States

Local Institution - 0065; 🇦🇷 Capital Federal, Distrito Federal, Argentina

Instituto Oncologico De Cordoba; 🇦🇷 Cordoba, Argentina

Local Institution - 0068; 🇦🇷 Capital Federal, Buenos Aires, Argentina

Local Institution; 🇬🇧 London, Greater London, United Kingdom

Local Institution - 0137; 🇦🇷 Mendoza, Argentina

Local Institution - 0148; 🇦🇺 St Leonards, New South Wales, Australia

Local Institution - 0151; 🇧🇷 Curitiba, Parana, Brazil

Local Institution - 0150; 🇧🇷 Rio de Janeiro, Brazil

Local Institution - 0078; 🇧🇷 Jau, Sao Paulo, Brazil

Local Institution - 0046; 🇨🇦 Quebec City, Quebec, Canada

Local Institution - 0074; 🇧🇷 Sao Paulo, Brazil

Local Institution - 0069; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0128; 🇨🇳 Beijing, Beijing, China

Local Institution - 0108; 🇨🇳 Fuzhou, Fujian, China

Deleware Valley Urology, LLC; 🇺🇸 Voorhees, New Jersey, United States

Local Institution - 0089; 🇦🇷 Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina

Local Institution - 0072; 🇧🇷 Fortaleza, Ceara, Brazil

Local Institution - 0057; 🇺🇸 Chattanooga, Tennessee, United States

Local Institution - 0077; 🇺🇸 Ann Arbor, Michigan, United States

Local Institution - 0002; 🇺🇸 Myrtle Beach, South Carolina, United States

Local Institution - 0143; 🇨🇦 North York, Ontario, Canada

Local Institution - 0088; 🇫🇷 Lille, France

Local Institution - 0091; 🇫🇷 Strasbourg, France

IRCCS Istituto Nazionale Tumori Milano; 🇮🇹 Milano, Italy

Local Institution - 0084; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0027; 🇫🇷 Suresnes, Hauts-de-Seine, France

Local Institution - 0031; 🇫🇷 Bordeaux Cedex, France

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, Italy

Local Institution - 0062; 🇲🇽 Tuxtla Gutierrez, Chiapas, Mexico

Local Institution - 0003; 🇳🇱 Nijmegen, Netherlands

Local Institution - 0005; 🇳🇱 Utrecht, Netherlands

Local Institution - 0070; 🇷🇺 Omsk, Russian Federation

Local Institution - 0054; 🇷🇺 Saint-Petersburg, Russian Federation