A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06319820
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non-Muscle Invasive Bladder Neoplasms

Eligibility Criteria

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

Interventions

  • TAR-210 — COMBINATION_PRODUCT
    TAR-210 will be administered intravesically.
  • Gemcitabine — DRUG
    Gemcitabine will be administered intravesically.
  • MMC — DRUG
    MMC will be administered intravesically.

Study Details

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Key Dates

Start date
Apr 18, 2024
Status verified
Jun 2026
Primary completion
Jun 28, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
641 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Main Study: Group A: TAR-210
    Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
  • Active Comparator: Main Study: Group B: MMC or Gemcitabine
    Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
  • Experimental: Substudy: Group A: TAR-210
    Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
  • Active Comparator: Substudy: Group B: MMC
    Participants in substudy Group B will receive intravesical MMC once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.

Primary Outcome Measure

Disease Free Survival (DFS) [ Time Frame: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months) ]

Central Contacts

Locations (38)

FacilityCityStateZIPSite coordinators
Arkansas UrologyLittle RockArkansas72211-
Genesis Research LLCLos AlamitosCalifornia90720-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Irvine Medical CenterOrangeCalifornia92868-
Om Research LLCSan DiegoCalifornia92123-
Genesis Research LLC 1Sherman OaksCalifornia91411-
University of Colorado Cancer Center Anschultz Cancer PavilionAuroraColorado80045-
Colorado Clinical ResearchLakewoodColorado80228-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern UniversityChicagoIllinois60611-
First UrologyJeffersonvilleIndiana47130-
Wichita Urology GroupWichitaKansas67226-
Ochsner Health SystemNew OrleansLouisiana70121-2429-
Chesapeake Urology Research AssociatesHanoverMaryland21076-
Brigham And Women's HospitalBostonMassachusetts02115-
Karmanos Cancer InstituteDetroitMichigan48201-
Comprehensive UrologyRoyal OakMichigan48073-
Mercy ResearchSt LouisMissouri63141-
Specialty Clinical Research of St LouisSt LouisMissouri63141-
The Urology Center, PCOmahaNebraska68114-
Cancer Institute Of New JerseyNew BrunswickNew Jersey08901-
Integrated Medical ProfessionalsNew YorkNew York10016-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Associated Medical Professionals of NySyracuseNew York13210-
SUNY Upstate Med UnivSyracuseNew York13210-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Associated Urologists of North CarolinaRaleighNorth Carolina27612-
MidLantic UrologyBala-CynwydPennsylvania19004-
Keystone Urology SpecialistsLancasterPennsylvania17604-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
The Conrad Pearson ClinicGermantownTennessee38138-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Urology AssociatesNashvilleTennessee37209-
Urology AustinAustinTexas78745-
Urology Clinics of North TexasDallasTexas75231-
UT SouthwesternDallasTexas75390-
Houston Metro UrologyHoustonTexas77027-
Spokane UrologySpokaneWashington99202-

Find similar trials in Little Rock, AR

By research site
Arkansas Urology· Little Rock, ARGenesis Research LLC· Los Alamitos, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Irvine Medical Center· Orange, CAOm Research LLC· San Diego, CAGenesis Research LLC 1· Sherman Oaks, CA

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