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

NCT03519256 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: CA209-9UT2017-003581-27
• Study Type: interventional
• Target: 142
• Locations: 15 countries
• Sites: 88

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.

Conditions

Urinary Bladder Neoplasms

Keywords

Bladder Cancer; BCG-unresponsive; Nivolumab; Intravesical BCG; NMIBC; Non-Muscle Invasive; BMS-986205; CheckMate 9UT

Outcome Measures

Primary Outcomes (10)

• Number of Participants With Adverse Events (AEs)

  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.

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants With Serious Adverse Events (SAEs)

  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.

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment

  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.

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants Immune-Mediated Adverse Events (IMAEs)

  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.

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants Who Died

  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 With Specific Liver Laboratory Abnormalities

  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.

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants With Specific Thyroid Laboratory Abnormalities

  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

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants With Changes From Baseline Laboratory Values

  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.

  From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status

  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.

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

• Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status

  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.

  From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

Study Arms (4)

Nivolumab monotherapy

EXPERIMENTAL

Biological: Nivolumab

Nivolumab + BCG

EXPERIMENTAL

Biological: Nivolumab; Biological: BCG

Nivolumab + BMS-986205

EXPERIMENTAL

Biological: Nivolumab; Drug: BMS-986205

Nivolumab + BMS-986205 + BCG

EXPERIMENTAL

Biological: Nivolumab; Biological: BCG; Drug: BMS-986205

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Nivolumab + BCG; Nivolumab + BMS-986205; Nivolumab + BMS-986205 + BCG; Nivolumab monotherapy

BCG BIOLOGICAL

Specified dose on specified days

Also known as: Bacillus Calumette-Guerin

Nivolumab + BCG; Nivolumab + BMS-986205 + BCG

BMS-986205 DRUG

Specified dose on specified days

Nivolumab + BMS-986205; Nivolumab + BMS-986205 + BCG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (88)

Local Institution - 0044

Los Angeles, California, 90033, United States

Location

Local Institution - 0081

Riverside, California, 92505, United States

Location

Local Institution - 0087

San Francisco, California, 94158, United States

Location

Local Institution - 0125

Tampa, Florida, 33612, United States

Location

Local Institution - 0056

Hapeville, Georgia, 30354, United States

Location

Local Institution - 0023

New Lenox, Illinois, 60451, United States

Location

Wichita Urology Group

Wichita, Kansas, 67226, United States

Location

Local Institution - 0001

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0077

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0032

Minneapolis, Minnesota, 55455, United States

Location

Local Institution - 0040

Omaha, Nebraska, 68114, United States

Location

Local Institution - 0144

New Brunswick, New Jersey, 08903, United States

Location

Deleware Valley Urology, LLC

Voorhees Township, New Jersey, 08043, United States

Location

Local Institution - 0051

New York, New York, 10016, United States

Location

Local Institution - 0058

Columbus, Ohio, 43212, United States

Location

Local Institution - 0036

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Local Institution - 0049

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0002

Myrtle Beach, South Carolina, 29572, United States

Location

Local Institution - 0057

Chattanooga, Tennessee, 37403, United States

Location

Urology Clinics Of North Texas, Pa

Dallas, Texas, 75231, United States

Location

Local Institution - 0048

Houston, Texas, 77030, United States

Location

Local Institution - 0140

Houston, Texas, 77030, United States

Location

Local Institution - 0047

Lubbock, Texas, 79415, United States

Location

Urology San Antonio Research, Pa

San Antonio, Texas, 78229, United States

Location

Local Institution - 0141

Seattle, Washington, 98195, United States

Location

Local Institution - 0068

Capital Federal, Buenos Aires, 1426, Argentina

Location

Local Institution - 0065

Capital Federal, Distrito Federal, C1280AEB, Argentina

Location

Local Institution - 0089

Ciudad Autonoma Buenos Aires, Distrito Federal, 1118, Argentina

Location

Local Institution

Viedma, Río Negro Province, 8500, Argentina

Location

Instituto Oncologico De Cordoba

Córdoba, 5000, Argentina

Location

Local Institution - 0137

Mendoza, 5500, Argentina

Location

Local Institution - 0146

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0148

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0072

Fortaleza, Ceará, 60135-237, Brazil

Location

Local Institution - 0151

Curitiba, Paraná, 80810050, Brazil

Location

Local Institution - 0073

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution

Itacorubi, Florianopolis, Santa Catarina, 88034, Brazil

Location

Local Institution - 0078

Jaú, São Paulo, 17210-120, Brazil

Location

Local Institution - 0150

Rio de Janeiro, 20230-130, Brazil

Location

Local Institution - 0074

São Paulo, 01246-000, Brazil

Location

Local Institution - 0143

North York, Ontario, M2K 1E1, Canada

Location

Local Institution - 0086

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution - 0084

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0046

Québec, Quebec, G1J 1Z4, Canada

Location

Local Institution - 0154

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0069

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0128

Beijing, Beijing Municipality, 100021, China

Location

Local Institution - 0131

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0116

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0099

Beijing, Beijing Municipality, 100191, China

Location

Local Institution - 0129

Chongqing, Chongqing Municipality, 400030, China

Location

Local Institution - 0108

Fuzhou, Fujian, 350001, China

Location

Local Institution - 0117

Guangzhou, Guangdong, 510000, China

Location

Local Institution - 0102

Nanjing, Jiangsu, 210008, China

Location

Local Institution - 0109

Nanchang, Jiangxi, 330000, China

Location

Local Institution - 0112

Jinan, Shandong, 250012, China

Location

Local Institution - 0111

Yantai, Shandong, 264000, China

Location

Local Institution - 0098

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0094

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0097

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution - 0120

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0133

Tianjin, Tianjin Municipality, 300211, China

Location

Local Institution - 0126

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0027

Suresnes, Hauts-de-Seine, 92151, France

Location

Local Institution - 0028

Angers, Maine-et-Loire, 49933, France

Location

Local Institution - 0031

Bordeaux, 33076, France

Location

Local Institution - 0088

Lille, 59037, France

Location

Local Institution - 0091

Strasbourg, 67200, France

Location

Local Institution - 0093

Hong Kong, Hong Kong

Location

IRCCS Istituto Nazionale Tumori Milano

Milan, 20133, Italy

Location

Instituto Nazionale Tumori Fondazione G. Pascale

Napoli, 80131, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

Location

Local Institution - 0062

Tuxtla Gutiérrez, Chiapas, 290838, Mexico

Location

Local Institution - 0055

Mexico City, Mexico City, 06100, Mexico

Location

Local Institution - 0004

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0003

Nijmegen, 6525GA, Netherlands

Location

Local Institution - 0005

Utrecht, 3584CX, Netherlands

Location

Local Institution - 0070

Omsk, 644013, Russia

Location

Local Institution - 0054

Saint Petersburg, 194044, Russia

Location

Local Institution - 0153

Saint Petersburg, 199034, Russia

Location

Local Institution

Madrid, 28041, Spain

Location

Local Institution - 0033

Málaga, 29010, Spain

Location

Local Institution - 0139

Santander, 39008, Spain

Location

Local Institution - 0136

Valencia, 46010, Spain

Location

Local Institution

Chelmsford, Essex, CM1 7ET, United Kingdom

Location

Local Institution

London, Greater London, N18 1QX, United Kingdom

Location

Local Institution - 0013

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 0015

Lancaster, LA1 4RP, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

Nivolumab; linrodostat

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

As of early April 2021, Study CA2099UT enrollment was significantly behind the projected target enrollment, (number of participants enrolled 142; target enrollment 480). Since the study would be unable to meet the scientific objectives within a projected timeline, a decision was made in May 2021 to close the study.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 8, 2018
• Study Start: August 2, 2018
• Primary Completion: August 22, 2022
• Study Completion: August 24, 2022
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Locations

AR (6); US (25); BR (7); CA (4); CL (2); IT (3); RU (3); ES (4); HK (1); AU (2); ME (2); FR (5); NL (3); CN (17); GB (4)