A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Part of paid clinical trials in Sun City, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06919965
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 — DRUG
    TAR-210 will be administered intravesically.
  • Mitomycin C — DRUG
    MMC will be administered intravesically.
  • Gemcitabine — DRUG
    Gemcitabine will be administered intravesically.

Study Details

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Key Dates

Start date
Sep 10, 2025
Status verified
Jun 2026
Primary completion
Apr 6, 2028
Completion
Mar 16, 2032

Study Design

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

Arms

  • Experimental: Group A: TAR-210
    Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years.
  • Active Comparator: Group B: Mitomycin C (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 maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.

Primary Outcome Measure

Disease-free Survival (DFS) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Academic Urology and Urogynecology of ArizonaSun CityArizona85351-
Colorado Clinical ResearchLakewoodColorado80228-
Georgia UrologyAtlantaGeorgia30328-
Associated Urological SpecialistsChicago RidgeIllinois60415-
Urology of IndianaCarmelIndiana46032-
Greater Boston UrologyPlymouthMassachusetts02360-
Comprehensive UrologyRoyal OakMichigan48073-
UroHealth PartnersOmahaNebraska68114-
New Jersey Urology LLCVoorhees TownshipNew Jersey08043-
Associated Medical ProfessionalsSyracuseNew York13210-
Dayton Physicians Network UrologyCentervilleOhio45459-
The Urology GroupCincinnatiOhio45212-
Helios Clinical Research, LLCMiddleburg HeightsOhio44130-
Oregon Urology InstituteSpringfieldOregon97477-
MidLantic UrologyBala-CynwydPennsylvania19004-
Keystone Urology SpecialistsLancasterPennsylvania17604-
University Of Pittsburgh Medical Center UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
The Conrad Pearson ClinicGermantownTennessee38138-
Texas Oncology-AustinAustinTexas78731-
Urology AustinAustinTexas78745-
Urology San Antonio PA dba USA Clinical TrialsSan AntonioTexas78229-

Find similar trials in Sun City, AZ

By research site
Academic Urology and Urogynecology of Arizona· Sun City, AZColorado Clinical Research· Lakewood, COGeorgia Urology· Atlanta, GAAssociated Urological Specialists· Chicago Ridge, ILUrology of Indiana· Carmel, INGreater Boston Urology· Plymouth, MA

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