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A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

NCT04149574

Description:

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Related Conditions:
  • Bladder Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)
  • Official Title: A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

Clinical Trial IDs

  • ORG STUDY ID: CA209-7G8
  • NCT ID: NCT04149574

Conditions

  • Bladder Cancer

Interventions

DrugSynonymsArms
nivolumabArm A: nivolumab
Bacillus Calmette-Guérin (BCG)Arm A: nivolumab

Purpose

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Trial Arms

NameTypeDescriptionInterventions
Arm A: nivolumabExperimental
  • nivolumab
  • Bacillus Calmette-Guérin (BCG)
Arm B: placebo +BCGPlacebo Comparator
  • Bacillus Calmette-Guérin (BCG)

Eligibility Criteria

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

        Inclusion:

          -  Predominant histologic component (> 50%) must be urothelial (transitional cell)
             carcinoma

          -  Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as
             BCG unresponsive

          -  Histologically confirmed persistent or recurrent high-risk non-muscle-invasive
             urothelial carcinoma (UC)

          -  Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6
             doses)

          -  Sufficient tissue for both biomarker analysis and central pathology review committee
             (PRC) confirmation of diagnosis

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

          -  Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to
             follow contraceptive requirements

        Exclusion Criteria

          -  Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic
             UC

          -  UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters)
             within 24 months of enrollment

          -  UC and/or CIS in the prostatic urethra within 12 months of enrollment

          -  Prior surgery (other than transurethral resection of the bladder tumor
             (TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic
             chemotherapy or immunotherapy for bladder cancer or UC

        Other inclusion/exclusion criteria apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event Free Survival (EFS)
Time Frame:approximately 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Worsening- Free Survival (WFS)
Time Frame:approximately 7 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:approximately 10 years
Safety Issue:
Description:
Measure:Complete Response Rate (CRR)
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Number of laboratory abnormalities
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Number of Laboratory changes from baseline
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Incidence of serious adverse Events (SAEs)
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Incidence of adverse events leading to discontinuation
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Incidence of immune-medicated adverse events (IMAEs)
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Incidence of Deaths
Time Frame:approximately 3 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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