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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

NCT03519256

Description:

A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer

Related Conditions:
  • Bladder Urothelial Carcinoma
  • Carcinoma In Situ
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-9UT
  • SECONDARY ID: 2017-003581-27
  • NCT ID: NCT03519256

Conditions

  • Bladder Cancer
  • Bladder Tumors
  • Neoplasms, Bladder

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Nivolumab monotherapy
BCGBacillus Calumette-GuerinNivolumab + BCG
BMS-986205Nivolumab + BMS-986205

Purpose

A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer

Trial Arms

NameTypeDescriptionInterventions
Nivolumab monotherapyExperimental
  • Nivolumab
Nivolumab + BCGExperimental
  • Nivolumab
  • BCG
Nivolumab + BMS-986205Experimental
  • Nivolumab
  • BMS-986205
Nivolumab + BMS-986205 + BCGExperimental
  • Nivolumab
  • BCG
  • BMS-986205

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Pathologically demonstrated BCG-unresponsive, high-risk non-muscle-invasive bladder
             cancer (NMIBC) defined as CIS with or without papillary component, any T1, or Ta
             high-grade lesions

          -  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/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC)
Time Frame:Up to 5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free Survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Incidence of AEs leading to discontinuation
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Up to 15 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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