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)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04149574
Phase
PHASE3
Status
Terminated

Conditions

  • Urinary Bladder Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — DRUG
    Specified Dose on Specified Days
  • Placebo — OTHER
    Specified Dose on Specified Days
  • Bacillus Calmette-Guérin (BCG) — BIOLOGICAL
    Specified Dose on Specified Days

Study Details

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.

Key Dates

Start date
Jan 15, 2020
Status verified
Aug 2025
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
  • Placebo Comparator: Arm B: placebo +BCG

Primary Outcome Measure

Part 2: Event Free Survival [ Time Frame: Approximately 44 Months and 1 Week ]

Locations (2)

FacilityCityStateZIPSite coordinators
The University Of ChicagoChicagoIllinois60637-
Local Institution - 0084The BronxNew York10461-

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By research site
The University Of Chicago· Chicago, ILLocal Institution - 0084· The Bronx, NY

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