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New bladder cancer treatment TAR-200 put to the test in everyday clinics

NCT ID NCT07309445

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study is tracking 150 people with early-stage bladder cancer who are receiving TAR-200, a treatment placed directly into the bladder. Researchers want to see how long it takes for the cancer to come back or get worse in real-world settings, not just in controlled trials. The goal is to understand if TAR-200 works well outside of research hospitals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAR-200 (a drug delivery system placed in the bladder to release chemotherapy locally)
What this could lead to
If successful, this study could show that TAR-200 is effective in everyday medical practice for delaying or preventing the return of early-stage bladder cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The drug is already approved, but real-world effectiveness can vary, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants aged 18 years or above with confirmed diagnosis of NMIBC (based on transurethral resection of bladder tumor \[TURBT\] or cold cup biopsy), who initiated the first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1 and willing to provide informed consent will be enrolled into the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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 criteria: * 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

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Associated Urological Specialists

    RECRUITING

    Chicago Ridge, Illinois, 60415, United States

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Colorado Clinical Research

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Florida Urology Partners

    RECRUITING

    Wimauma, Florida, 33598, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Low Country Urology Clinics

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Michigan Institute of Urology

    RECRUITING

    Troy, Michigan, 48084, United States

  • SUNY Upstate Med Univ

    RECRUITING

    Syracuse, New York, 13210, United States

  • Specialty Clinical Research of St Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Spokane Urology

    RECRUITING

    Spokane, Washington, 99202, United States

  • UPNT Research Institute

    RECRUITING

    Arlington, Texas, 76017, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Washington School of Medicine

    RECRUITING

    Seattle, Washington, 98195, United States

  • Urology Specialists of South Dakota

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Urology Specialists of the Carolinas PLLC Charlotte

    RECRUITING

    Charlotte, North Carolina, 28204, United States

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