Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

BCG Vaccine

Linrodostat

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

BMS-986205

Bristol-Myers Squibb

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.

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

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

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.

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.

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.

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.

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.

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

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.

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.

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.

Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).

Arm A: Nivolumab

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.

Arm B: Nivolumab Plus Intravesical BCG

Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).

Arm C: Nivolumab Plus BMS-986205

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.

Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Asian

Race/Ethnicity, Customized

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

Bristol-Myers Squibb Study Director

All randomized participants who received at least one dose of any study medication.

Number of Participants With Adverse Events (AEs)

Number of Participants With Serious Adverse Events (SAEs)

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

Number of Participants Immune-Mediated Adverse Events (IMAEs)

Number of Participants Who Died

ALT OR AST > 3XULN

ALT OR AST> 5XULN

ALT OR AST> 10XULN

ALT OR AST > 20XULN

TOTAL BILIRUBIN > 2XULN

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYs

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS

ALP>1.5XULN

All randomized participants who received at least one dose of any study medication and had at least one on-treatment liver laboratory measurement.

Number of Participants With Specific Liver Laboratory Abnormalities

TSH > ULN

TSH > ULN WITH TSH <= ULN AT BASELINE

TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN

TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN

TSH > ULN WITH FT3/FT4 TEST MISSING

TSH < LLN

TSH <LLN WITH TSH >= LLN AT BASELINE

TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN

TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN

TSH < LLN WITH FT3/FT4 TEST MISSING

All randomized participants who received at least one dose of any study medication and had at least one on-treatment thyroid laboratory measurement.

Number of Participants With Specific Thyroid Laboratory Abnormalities

Hemoglobin

Platelet Count

Leukocytes, Local Lab

Lymphocytes (Absolute)

Lymphocytes (Absolute), Local Lab

Absolute Neutrophil Count

Alkaline Phosphatase (ALP), Local Lab

Aspartate Aminotransferase (AST), Local Lab

Alanine Aminotransferase (ALT), Local Lab

Bilirubin Total, Local Lab

Creatinine, Local Lab

Hypernatremia

Hyponatremia

Hyperkalemia

Hypokalemia

Hypercalcemia

Hypocalcemia

Hypermagnesemia

Hypomagnesemia

Hyperglycemia

Hypoglycemia

All randomized participants who received at least one dose of any study medication and had at least one on-study select laboratory measurement.

Number of Participants With Changes From Baseline Laboratory Values

Nivolumab ADA Positive

Nivolumab ADA Negative

All randomized participants who received at least one dose of any study medication and had evaluable ADA status.

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

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

Overall Study

Spots Global Cancer Trial Database for checkmate 9ut