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BMS-986205 for Bladder Cancer (CheckMate 9UT Trial)

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

CheckMate 9UT Trial Summary

This trial will study whether the immunotherapy drug nivolumab, with or without the addition of another drug, is safe and tolerated in patients with bladder cancer that has not responded to BCG treatment.

CheckMate 9UT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CheckMate 9UT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Immune-Mediated Adverse Events (IMAEs)
Number of Participants Who Died
Number of Participants With Adverse Events (AEs)
+7 more
Secondary outcome measures
Incidence of AEs leading to discontinuation
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
+3 more

CheckMate 9UT Trial Design

4Treatment groups
Experimental Treatment
Group I: Nivolumab monotherapyExperimental Treatment1 Intervention
Group II: Nivolumab + BMS-986205 + BCGExperimental Treatment3 Interventions
Group III: Nivolumab + BMS-986205Experimental Treatment2 Interventions
Group IV: Nivolumab + BCGExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
BMS-986205
2017
Completed Phase 3
~1200
BCG
2015
Completed Phase 4
~3220

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,631 Previous Clinical Trials
4,126,529 Total Patients Enrolled

Frequently Asked Questions

~22 spots leftby Mar 2025