Back to resultsA 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 (CheckMate 9UT)
Primary Purpose
Urinary Bladder Neoplasms
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
BCG
BMS-986205
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring Bladder Cancer, BCG-unresponsive, Nivolumab, Intravesical BCG, NMIBC, Non-Muscle Invasive, BMS-986205, CheckMate 9UT
Eligibility Criteria
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
Sites / Locations
- Local Institution - 0044
- Local Institution - 0081
- Local Institution - 0087
- Local Institution - 0125
- Local Institution - 0056
- Local Institution - 0023
- Wichita Urology Group
- Local Institution - 0001
- Local Institution - 0077
- Local Institution - 0032
- Local Institution - 0040
- Local Institution - 0144
- Deleware Valley Urology, LLC
- Local Institution - 0051
- Local Institution - 0058
- Local Institution - 0036
- Local Institution - 0049
- Local Institution - 0002
- Local Institution - 0057
- Urology Clinics Of North Texas, Pa
- Local Institution - 0048
- Local Institution - 0140
- Local Institution - 0047
- Urology San Antonio Research, Pa
- Local Institution - 0141
- Local Institution - 0068
- Local Institution - 0065
- Local Institution - 0089
- Local Institution
- Instituto Oncologico De Cordoba
- Local Institution - 0137
- Local Institution - 0146
- Local Institution - 0148
- Local Institution - 0072
- Local Institution - 0151
- Local Institution - 0073
- Local Institution
- Local Institution - 0078
- Local Institution - 0150
- Local Institution - 0074
- Local Institution - 0143
- Local Institution - 0086
- Local Institution - 0084
- Local Institution - 0046
- Local Institution - 0154
- Local Institution - 0069
- Local Institution - 0128
- Local Institution - 0131
- Local Institution - 0116
- Local Institution - 0099
- Local Institution - 0129
- Local Institution - 0108
- Local Institution - 0117
- Local Institution - 0102
- Local Institution - 0109
- Local Institution - 0112
- Local Institution - 0111
- Local Institution - 0098
- Local Institution - 0094
- Local Institution - 0097
- Local Institution - 0120
- Local Institution - 0133
- Local Institution - 0126
- Local Institution - 0027
- Local Institution - 0028
- Local Institution - 0031
- Local Institution - 0088
- Local Institution - 0091
- Local Institution - 0093
- IRCCS Istituto Nazionale Tumori Milano
- Instituto Nazionale Tumori Fondazione G. Pascale
- Azienda Ospedaliera Universitaria Pisana
- Local Institution - 0062
- Local Institution - 0055
- Local Institution - 0004
- Local Institution - 0003
- Local Institution - 0005
- Local Institution - 0070
- Local Institution - 0054
- Local Institution - 0153
- Local Institution
- Local Institution - 0033
- Local Institution - 0139
- Local Institution - 0136
- Local Institution
- Local Institution
- Local Institution - 0013
- Local Institution - 0015
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Nivolumab monotherapy
Nivolumab + BCG
Nivolumab + BMS-986205
Nivolumab + BMS-986205 + BCG
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Number of Participants Who Died
Number of participants who died.
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.
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
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03519256
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Enrollment
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms
Keywords
Bladder Cancer, BCG-unresponsive, Nivolumab, Intravesical BCG, NMIBC, Non-Muscle Invasive, BMS-986205, CheckMate 9UT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab monotherapy
Arm Type
Experimental
Arm Title
Nivolumab + BCG
Arm Type
Experimental
Arm Title
Nivolumab + BMS-986205
Arm Type
Experimental
Arm Title
Nivolumab + BMS-986205 + BCG
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
BCG
Other Intervention Name(s)
Bacillus Calumette-Guerin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986205
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment
Description
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.
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants Immune-Mediated Adverse Events (IMAEs)
Description
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.
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants Who Died
Description
Number of participants who died.
Time Frame
From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)
Title
Number of Participants With Specific Liver Laboratory Abnormalities
Description
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.
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants With Specific Thyroid Laboratory Abnormalities
Description
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
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants With Changes From Baseline Laboratory Values
Description
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.
Time Frame
From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status
Description
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.
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Title
Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status
Description
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.
Time Frame
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0044
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution - 0081
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Local Institution - 0087
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Local Institution - 0125
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 0056
City
Hapeville
State/Province
Georgia
ZIP/Postal Code
30354
Country
United States
Facility Name
Local Institution - 0023
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
Wichita Urology Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Local Institution - 0001
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Local Institution - 0077
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution - 0032
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Local Institution - 0040
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Local Institution - 0144
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Deleware Valley Urology, LLC
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Local Institution - 0051
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0058
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Local Institution - 0036
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Local Institution - 0049
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0002
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Local Institution - 0057
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Urology Clinics Of North Texas, Pa
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Local Institution - 0048
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0140
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0047
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
Urology San Antonio Research, Pa
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Local Institution - 0141
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Local Institution - 0068
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0065
City
Capital Federal
State/Province
Distrito Federal
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Local Institution - 0089
City
Ciudad Autonoma Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1118
Country
Argentina
Facility Name
Local Institution
City
Viedma
State/Province
RIO Negro
ZIP/Postal Code
8500
Country
Argentina
Facility Name
Instituto Oncologico De Cordoba
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0137
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Local Institution - 0146
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0148
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution - 0072
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Facility Name
Local Institution - 0151
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810050
Country
Brazil
Facility Name
Local Institution - 0073
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution
City
Itacorubi, Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034
Country
Brazil
Facility Name
Local Institution - 0078
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Local Institution - 0150
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Local Institution - 0074
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Local Institution - 0143
City
North York
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
Local Institution - 0086
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Local Institution - 0084
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0046
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Local Institution - 0154
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0069
City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
Local Institution - 0128
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Local Institution - 0131
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Local Institution - 0116
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution - 0099
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Local Institution - 0129
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Local Institution - 0108
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Local Institution - 0117
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Local Institution - 0102
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Local Institution - 0109
City
Nan Chang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
Local Institution - 0112
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Local Institution - 0111
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Local Institution - 0098
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Local Institution - 0094
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution - 0097
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Local Institution - 0120
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution - 0133
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Local Institution - 0126
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 0027
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92151
Country
France
Facility Name
Local Institution - 0028
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Local Institution - 0031
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution - 0088
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0091
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Local Institution - 0093
City
Hong Kong
Country
Hong Kong
Facility Name
IRCCS Istituto Nazionale Tumori Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Instituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Local Institution - 0062
City
Tuxtla Gutierrez
State/Province
Chiapas
ZIP/Postal Code
290838
Country
Mexico
Facility Name
Local Institution - 0055
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Local Institution - 0004
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution - 0003
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands
Facility Name
Local Institution - 0005
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Local Institution - 0070
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Local Institution - 0054
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Local Institution - 0153
City
Saint-Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0033
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0139
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0136
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Local Institution - 0013
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution - 0015
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
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
We'll reach out to this number within 24 hrs