A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07309445
Status
Recruiting
Apply to this trial

Conditions

  • Non-Muscle Invasive Bladder Neoplasms

Eligibility Criteria

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

Study Details

The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).

Key Dates

First listed
Dec 30, 2025
Start date
Jun 12, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2029
Completion
Oct 9, 2029

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: NMIBC Participants: Routine Clinical Practice Setting
    Participants with confirmed diagnosis of NMIBC and who have initiated first dose of TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200, or until the participant dies, is lost to follow-up, or withdraws consent in the study. No intervention will be administered as a part of this study.

Primary Outcome Measure

Disease-Free Survival (DFS) [ Time Frame: Up to 24 months ]

Central Contacts

  • Study Contact
    844-434-4210
    [email protected]
  • Eliza M. Raymundo, MD, DMCC, FPUA, FPCS
    1-669-800-7705

Locations (13)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Arkansas UrologyLittle RockArkansas72211-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Colorado Clinical ResearchLakewoodColorado80228-
Florida Urology PartnersWimaumaFlorida33598-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Specialty Clinical Research of St LouisSt LouisMissouri63141-
SUNY Upstate Med UnivSyracuseNew York13210-
Urology Specialists of the Carolinas PLLC CharlotteCharlotteNorth Carolina28204-
Urology Specialists of South DakotaSioux FallsSouth Dakota57108-
UPNT Research InstituteArlingtonTexas76017-
Spokane UrologySpokaneWashington99202-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALArkansas Urology· Little Rock, ARCedars Sinai Medical Center· Los Angeles, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAColorado Clinical Research· Lakewood, COFlorida Urology Partners· Wimauma, FL

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