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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03519256
Phase
PHASE2
Status
Terminated

Conditions

  • Urinary Bladder Neoplasms

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • BCG — BIOLOGICAL
    Specified dose on specified days
  • BMS-986205 — DRUG
    Specified dose on specified days

Study Details

A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.

Key Dates

Start date
Aug 2, 2018
Status verified
May 2023
Primary completion
Aug 22, 2022
Completion
Aug 24, 2022

Study Design

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

Arms

  • Experimental: Nivolumab monotherapy
  • Experimental: Nivolumab + BCG
  • Experimental: Nivolumab + BMS-986205
  • Experimental: Nivolumab + BMS-986205 + BCG

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Local Institution - 0044Los AngelesCalifornia90033-
Local Institution - 0081RiversideCalifornia92505-
Local Institution - 0087San FranciscoCalifornia94158-
Local Institution - 0125TampaFlorida33612-
Local Institution - 0056HapevilleGeorgia30354-
Local Institution - 0023New LenoxIllinois60451-
Wichita Urology GroupWichitaKansas67226-
Local Institution - 0001BaltimoreMaryland21287-
Local Institution - 0077Ann ArborMichigan48109-
Local Institution - 0032MinneapolisMinnesota55455-
Local Institution - 0040OmahaNebraska68114-
Local Institution - 0144New BrunswickNew Jersey08903-
Deleware Valley Urology, LLCVoorhees TownshipNew Jersey08043-
Local Institution - 0051New YorkNew York10016-
Local Institution - 0058ColumbusOhio43212-
Local Institution - 0036Bala-CynwydPennsylvania19004-
Local Institution - 0049CharlestonSouth Carolina29425-
Local Institution - 0002Myrtle BeachSouth Carolina29572-
Local Institution - 0057ChattanoogaTennessee37403-
Urology Clinics Of North Texas, PaDallasTexas75231-
Local Institution - 0048HoustonTexas77030-
Local Institution - 0140HoustonTexas77030-
Local Institution - 0047LubbockTexas79415-
Urology San Antonio Research, PaSan AntonioTexas78229-
Local Institution - 0141SeattleWashington98195-

Find similar trials in Los Angeles, CA

By research site
Local Institution - 0044· Los Angeles, CALocal Institution - 0081· Riverside, CALocal Institution - 0087· San Francisco, CALocal Institution - 0125· Tampa, FLLocal Institution - 0056· Hapeville, GALocal Institution - 0023· New Lenox, IL

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