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Observational Study of TAR-200 for Non-Muscle Invasive Bladder Cancer

This study is looking at how TAR-200 works in real-world settings for people with non-muscle invasive bladder cancer (NMIBC), which is an early-stage bladder cancer. Researchers want to see how long patients remain free from cancer worsening or returning after starting TAR-200. You might be able to join if you have a confirmed NMIBC diagnosis and have started TAR-200 within the last six weeks. The study aims to enroll about 150 participants. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch how TAR-200 is used in real-world settings. It plans to include about 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months to measure how long they remain disease-free.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07309445

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

Recruiting
Not specifiedAges 18+Observational
Janssen Research & Development, LLC
~150 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Free Survival (DFS)
Measured over Up to 24 months

Conditions

Non-Muscle Invasive Bladder Neoplasms

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NCT07309445

Where you'd take part

This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arkansas Urology

    Little Rock, Arkansasno site contact published

    Recruiting

  • Associated Urological Specialists

    Chicago Ridge, Illinoisno site contact published

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, Californiano site contact published

    Recruiting

  • Colorado Clinical Research

    Lakewood, Coloradono site contact published

    Recruiting

  • Florida Urology Partners

    Wimauma, Floridano site contact published

    Recruiting

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indianano site contact published

    Recruiting

  • Low Country Urology Clinics

    North Charleston, South Carolinano site contact published

    Recruiting

  • Michigan Institute of Urology

    Troy, Michiganno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Eligibility criteria

Inclusion

Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy
Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1
Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice
Must provide informed consent as described in the protocol

Exclusion

Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1
Previously received TAR-200 intravesically as part of a clinical trial(s)
Previously received greater than (\>) 2 doses/cycles of TAR-200 in the real-world setting
Currently participating in an interventional bladder cancer clinical trial

What this trial measures

  • Disease-Free Survival (DFS)Up to 24 months

    DFS is defined as the time from first TAR-200 initiation date to the time of the first recurrence of NMIBC (Ta, any T1 or carcinoma in-situ \[CIS)\], progression (to muscle invasive bladder cancer \[MIBC; T greater than or equal to {\>=} 2\] or to lymph node \[N+\] or to distant disease \[M+\], whichever occurs first), or death due NMIBC, whichever occurs first.