Urinary Bladder Neoplasms
Conditions
Keywords
Bladder Cancer, BCG-unresponsive, Nivolumab, Intravesical BCG, NMIBC, Non-Muscle Invasive, BMS-986205, CheckMate 9UT
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.
Interventions
BIOLOGICALNivolumab
Specified dose on specified days
BIOLOGICALBCG
Specified dose on specified days
DRUGBMS-986205
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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. |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, France, Hong Kong, Italy, Mexico, Netherlands, Russia, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
A safety lead-in was conducted in participants randomized to receive bacillus Calmette-Guerin (BCG) and nivolumab without BMS-986205 (Arm B), and Nivolumab Plus BMS-986205 Plus Intravesical BCG (Arm D) to determine safe-dose levels to be administered during the treatment phase.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Nivolumab Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months). | 16 |
| Arm B: Nivolumab Plus Intravesical BCG Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose. | 26 |
| Arm C: Nivolumab Plus BMS-986205 Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months). | 17 |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose. | 10 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse event unrelated to study drug | 0 | 1 | 1 | 0 |
| Overall Study | Disease progression | 6 | 3 | 2 | 1 |
| Overall Study | Disease recurrence | 4 | 4 | 5 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Other reasons | 0 | 0 | 2 | 0 |
| Overall Study | Participant request to discontinue study treatment | 0 | 0 | 0 | 2 |
| Overall Study | Study drug toxicity | 0 | 2 | 5 | 2 |
Baseline characteristics
| Characteristic | Arm A: Nivolumab | Arm B: Nivolumab Plus Intravesical BCG | Arm C: Nivolumab Plus BMS-986205 | Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.8 Years STANDARD_DEVIATION 11.1 | 69.0 Years STANDARD_DEVIATION 9.4 | 69.1 Years STANDARD_DEVIATION 12.3 | 69.9 Years STANDARD_DEVIATION 16.4 | 67.5 Years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 23 Participants | 8 Participants | 9 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 6 Participants | 0 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 26 Participants | 17 Participants | 10 Participants | 66 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 5 Participants | 1 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 22 Participants | 12 Participants | 9 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 3 / 26 | 2 / 17 | 0 / 10 |
| other Total, other adverse events | 15 / 16 | 26 / 26 | 15 / 17 | 10 / 10 |
| serious Total, serious adverse events | 4 / 16 | 7 / 26 | 7 / 17 | 5 / 10 |
Outcome results
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.
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Nivolumab | Number of Participants Immune-Mediated Adverse Events (IMAEs) | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants Immune-Mediated Adverse Events (IMAEs) | 10 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants Immune-Mediated Adverse Events (IMAEs) | 6 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants Immune-Mediated Adverse Events (IMAEs) | 5 Participants |
Primary
Number of Participants Who Died
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)
Population: All randomized participants who received at least one dose of any study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Nivolumab | Number of Participants Who Died | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants Who Died | 3 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants Who Died | 2 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants Who Died | 0 Participants |
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.
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Nivolumab | Number of Participants With Adverse Events (AEs) | 15 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Adverse Events (AEs) | 26 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Adverse Events (AEs) | 15 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Adverse Events (AEs) | 10 Participants |
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.
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication and had evaluable ADA status.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab | Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 11 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Positive | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 21 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Positive | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 11 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 9 Participants |
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.
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Nivolumab | Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment | 4 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment | 8 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment | 7 Participants |
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.
Time frame: From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication and had at least one on-study select laboratory measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hemoglobin | 1 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Platelet Count | 1 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Leukocytes, Local Lab | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute) | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute), Local Lab | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Absolute Neutrophil Count | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Alkaline Phosphatase (ALP), Local Lab | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Aspartate Aminotransferase (AST), Local Lab | 3 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Alanine Aminotransferase (ALT), Local Lab | 4 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Bilirubin Total, Local Lab | 1 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Creatinine, Local Lab | 1 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hypernatremia | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hyponatremia | 4 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hyperkalemia | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hypokalemia | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hypercalcemia | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hypocalcemia | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hypermagnesemia | 3 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hypomagnesemia | 1 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hyperglycemia | 4 Participants |
| Arm A: Nivolumab | Number of Participants With Changes From Baseline Laboratory Values | Hypoglycemia | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypermagnesemia | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hemoglobin | 7 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Aspartate Aminotransferase (AST), Local Lab | 5 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypernatremia | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Alkaline Phosphatase (ALP), Local Lab | 2 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypercalcemia | 4 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypokalemia | 2 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hyponatremia | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Leukocytes, Local Lab | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hyperglycemia | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypocalcemia | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hyperkalemia | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Alanine Aminotransferase (ALT), Local Lab | 10 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute), Local Lab | 7 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Absolute Neutrophil Count | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypoglycemia | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Bilirubin Total, Local Lab | 2 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute) | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Platelet Count | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypomagnesemia | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Creatinine, Local Lab | 8 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Platelet Count | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Absolute Neutrophil Count | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Alkaline Phosphatase (ALP), Local Lab | 2 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hypermagnesemia | 2 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Aspartate Aminotransferase (AST), Local Lab | 12 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Alanine Aminotransferase (ALT), Local Lab | 13 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Bilirubin Total, Local Lab | 5 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Creatinine, Local Lab | 3 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hypomagnesemia | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hypernatremia | 4 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hyponatremia | 4 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hypoglycemia | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hyperkalemia | 2 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hypokalemia | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hyperglycemia | 3 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hypercalcemia | 0 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hemoglobin | 5 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Leukocytes, Local Lab | 4 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Hypocalcemia | 2 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute) | 3 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute), Local Lab | 2 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypercalcemia | 3 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Creatinine, Local Lab | 5 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypocalcemia | 2 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hemoglobin | 6 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hyperglycemia | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Bilirubin Total, Local Lab | 3 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Alanine Aminotransferase (ALT), Local Lab | 7 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Platelet Count | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypermagnesemia | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Aspartate Aminotransferase (AST), Local Lab | 3 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Absolute Neutrophil Count | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Leukocytes, Local Lab | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypoglycemia | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hyperkalemia | 3 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hyponatremia | 3 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypomagnesemia | 3 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Alkaline Phosphatase (ALP), Local Lab | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypokalemia | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute), Local Lab | 5 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Hypernatremia | 2 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Changes From Baseline Laboratory Values | Lymphocytes (Absolute) | 0 Participants |
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.
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Nivolumab | Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Serious Adverse Events (SAEs) | 6 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
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.
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication and had evaluable ADA status.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Positive | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Positive | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Positive | 0 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 4 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Positive | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status | Nivolumab ADA Negative | 4 Participants |
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.
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication and had at least one on-treatment liver laboratory measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 5XULN | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 20XULN | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYs | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 3XULN | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 10XULN | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY | 0 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Liver Laboratory Abnormalities | ALP>1.5XULN | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 3XULN | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALP>1.5XULN | 2 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 10XULN | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 20XULN | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 5XULN | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYs | 0 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 10XULN | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALP>1.5XULN | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYs | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 5XULN | 5 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 20XULN | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 3XULN | 7 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Liver Laboratory Abnormalities | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALP>1.5XULN | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 3XULN | 2 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 5XULN | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST> 10XULN | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT OR AST > 20XULN | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYs | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Liver Laboratory Abnormalities | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
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
Time frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Population: All randomized participants who received at least one dose of any study medication and had at least one on-treatment thyroid laboratory measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN | 5 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH TSH <= ULN AT BASELINE | 4 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH TSH >= LLN AT BASELINE | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 2 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm A: Nivolumab | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH TSH >= LLN AT BASELINE | 3 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN | 5 Participants |
| Arm B: Nivolumab Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH TSH <= ULN AT BASELINE | 5 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH TSH >= LLN AT BASELINE | 3 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN | 2 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN | 3 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm C: Nivolumab Plus BMS-986205 | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 2 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH > ULN | 1 Participants |
| Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG | Number of Participants With Specific Thyroid Laboratory Abnormalities | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |