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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03519256
Registration number
NCT03519256
Ethics application status
Date submitted
17/04/2018
Date registered
8/05/2018
Date last updated
1/06/2023
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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2017-003581-27
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Secondary ID [2]
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CA209-9UT
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 9UT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - BCG
Treatment: Drugs - BMS-986205
Experimental: Nivolumab monotherapy -
Experimental: Nivolumab + BCG -
Experimental: Nivolumab + BMS-986205 -
Experimental: Nivolumab + BMS-986205 + BCG -
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Other: BCG
Specified dose on specified days
Treatment: Drugs: BMS-986205
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
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Primary outcome [2]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
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Primary outcome [3]
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Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
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Primary outcome [4]
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Number of Participants Immune-Mediated Adverse Events (IMAEs)
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Assessment method [4]
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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.
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Timepoint [4]
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Primary outcome [5]
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Number of Participants Who Died
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Assessment method [5]
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Number of participants who died.
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Timepoint [5]
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From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)
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Primary outcome [6]
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Number of Participants With Specific Liver Laboratory Abnormalities
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Assessment method [6]
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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.
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Timepoint [6]
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Primary outcome [7]
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Number of Participants With Specific Thyroid Laboratory Abnormalities
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Assessment method [7]
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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
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Timepoint [7]
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Primary outcome [8]
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Number of Participants With Changes From Baseline Laboratory Values
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Assessment method [8]
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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.
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Timepoint [8]
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From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
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Primary outcome [9]
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Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status
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Assessment method [9]
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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.
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Timepoint [9]
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From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
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Primary outcome [10]
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Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status
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Assessment method [10]
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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.
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Timepoint [10]
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From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/08/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/08/2022
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Sample size
Target
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Accrual to date
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Final
142
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Local Institution - 0146 - Camperdown
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Recruitment hospital [2]
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Local Institution - 0148 - St Leonards
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment outside Australia
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United States of America
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California
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Florida
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Lancaster
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03519256
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/56/NCT03519256/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/56/NCT03519256/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03519256
Download to PDF