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Brief Title: Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

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

INTRODUCTION

  • Org Study ID: CA209-7G8
  • Secondary ID: N/A
  • NCT ID: NCT04149574
  • Sponsor: Bristol-Myers Squibb

BRIEF SUMMARY

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.

  • Overall Status
    Active, not recruiting
  • Start Date
    January 15, 2020
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

Inclusion Criteria:
* 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)

- * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
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
Other protocol-defined inclusion/exclusion criteria apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact