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

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT03519256

Acronym / sponsor ID

CheckMate 9UT / CA209-9UT

Conditions

Urinary Bladder Neoplasms

Keywords

Bladder Cancer, BCG-unresponsive, Nivolumab, Intravesical BCG, NMIBC, Non-Muscle Invasive, BMS-986205, CheckMate 9UT

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Insufficient Enrollment

Enrolment

142 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

2 Aug 2018 (actual)

Primary completion

22 Aug 2022 (actual)

Study completion

24 Aug 2022 (actual)

First posted

8 May 2018 (actual)

Results

Posted 1 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

4

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Adverse Events (AEs)

   Time frame: 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.

2. Number of Participants With Serious Adverse Events (SAEs)

   Time frame: 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.

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

   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.

4. Number of Participants Immune-Mediated Adverse Events (IMAEs)

   Time frame: 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.

5. 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)

   Number of participants who died.

6. Number of Participants With Specific Liver Laboratory Abnormalities

   Time frame: 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.

7. Number of Participants With Specific Thyroid Laboratory Abnormalities

   Time frame: 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

8. Number of Participants With Changes From Baseline Laboratory Values

   Time frame: 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.

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

   Time frame: 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.

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

    Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

88 sites in 15 countries: see every site and its status.