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

Urinary Bladder Neoplasms Clinical Trial

— CheckMate 9UT  

Official title:

A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03519256
• Other study ID #: CA209-9UT
• Secondary ID: 2017-003581-27
• Status: Terminated
• Phase: Phase 2
• Start date: August 2, 2018
• Est. completion date: August 24, 2022

Study information

• Verified date: May 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: August 24, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Urinary Bladder Neoplasms

Intervention

Biological:
• Nivolumab
Specified dose on specified days
• BCG
Specified dose on specified days

Drug:
• BMS-986205
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0065	Capital Federal	Distrito Federal
Argentina	Local Institution - 0068	Capital Federal	Buenos Aires
Argentina	Local Institution - 0089	Ciudad Autonoma Buenos Aires	Distrito Federal
Argentina	Instituto Oncologico De Cordoba	Cordoba
Argentina	Local Institution - 0137	Mendoza
Argentina	Local Institution	Viedma	RIO Negro
Australia	Local Institution - 0146	Camperdown	New South Wales
Australia	Local Institution - 0148	St Leonards	New South Wales
Brazil	Local Institution - 0151	Curitiba	Parana
Brazil	Local Institution - 0072	Fortaleza	Ceara
Brazil	Local Institution	Itacorubi, Florianopolis	Santa Catarina
Brazil	Local Institution - 0078	Jau	Sao Paulo
Brazil	Local Institution - 0073	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0150	Rio de Janeiro
Brazil	Local Institution - 0074	Sao Paulo
Canada	Local Institution - 0143	North York	Ontario
Canada	Local Institution - 0046	Quebec City	Quebec
Canada	Local Institution - 0084	Toronto	Ontario
Canada	Local Institution - 0086	Toronto	Ontario
Chile	Local Institution - 0069	Santiago	Metropolitana
Chile	Local Institution - 0154	Santiago	Metropolitana
China	Local Institution - 0099	Beijing	Beijing
China	Local Institution - 0116	Beijing	Beijing
China	Local Institution - 0128	Beijing	Beijing
China	Local Institution - 0131	Beijing	Beijing
China	Local Institution - 0120	Chengdu	Sichuan
China	Local Institution - 0129	Chongqing	Chongqing
China	Local Institution - 0108	Fuzhou	Fujian
China	Local Institution - 0117	Guangzhou	Guangdong
China	Local Institution - 0126	Hangzhou	Zhejiang
China	Local Institution - 0112	Jinan	Shandong
China	Local Institution - 0109	Nan Chang	Jiangxi
China	Local Institution - 0102	Nanjing	Jiangsu
China	Local Institution - 0094	Shanghai	Shanghai
China	Local Institution - 0097	Shanghai	Shanghai
China	Local Institution - 0098	Shanghai	Shanghai
China	Local Institution - 0133	Tianjin	Tianjin
China	Local Institution - 0111	Yantai	Shandong
France	Local Institution - 0028	Angers	Maine-et-Loire
France	Local Institution - 0031	Bordeaux Cedex
France	Local Institution - 0088	Lille
France	Local Institution - 0091	Strasbourg
France	Local Institution - 0027	Suresnes	Hauts-de-Seine
Hong Kong	Local Institution - 0093	Hong Kong
Italy	IRCCS Istituto Nazionale Tumori Milano	Milano
Italy	Instituto Nazionale Tumori Fondazione G. Pascale	Napoli
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Mexico	Local Institution - 0055	Ciudad de Mexico	Distrito Federal
Mexico	Local Institution - 0062	Tuxtla Gutierrez	Chiapas
Netherlands	Local Institution - 0004	Amsterdam
Netherlands	Local Institution - 0003	Nijmegen
Netherlands	Local Institution - 0005	Utrecht
Russian Federation	Local Institution - 0070	Omsk
Russian Federation	Local Institution - 0054	Saint-Petersburg
Russian Federation	Local Institution - 0153	Saint-Petersburg
Spain	Local Institution	Madrid
Spain	Local Institution - 0033	Malaga
Spain	Local Institution - 0139	Santander
Spain	Local Institution - 0136	Valencia
United Kingdom	Local Institution	Chelmsford	Essex
United Kingdom	Local Institution - 0015	Lancaster
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution - 0013	Southampton	Hampshire
United States	Local Institution - 0077	Ann Arbor	Michigan
United States	Local Institution - 0036	Bala-Cynwyd	Pennsylvania
United States	Local Institution - 0001	Baltimore	Maryland
United States	Local Institution - 0049	Charleston	South Carolina
United States	Local Institution - 0057	Chattanooga	Tennessee
United States	Local Institution - 0058	Columbus	Ohio
United States	Urology Clinics Of North Texas, Pa	Dallas	Texas
United States	Local Institution - 0056	Hapeville	Georgia
United States	Local Institution - 0048	Houston	Texas
United States	Local Institution - 0140	Houston	Texas
United States	Local Institution - 0044	Los Angeles	California
United States	Local Institution - 0047	Lubbock	Texas
United States	Local Institution - 0032	Minneapolis	Minnesota
United States	Local Institution - 0002	Myrtle Beach	South Carolina
United States	Local Institution - 0144	New Brunswick	New Jersey
United States	Local Institution - 0023	New Lenox	Illinois
United States	Local Institution - 0051	New York	New York
United States	Local Institution - 0040	Omaha	Nebraska
United States	Local Institution - 0081	Riverside	California
United States	Urology San Antonio Research, Pa	San Antonio	Texas
United States	Local Institution - 0087	San Francisco	California
United States	Local Institution - 0141	Seattle	Washington
United States	Local Institution - 0125	Tampa	Florida
United States	Deleware Valley Urology, LLC	Voorhees	New Jersey
United States	Wichita Urology Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  China,  France,  Hong Kong,  Italy,  Mexico,  Netherlands,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting