NCT07309445From ClinicalTrials.govRecruiting

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

A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US

Non-Muscle Invasive Bladder Neoplasms

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: Janssen Research & Development, LLC
Enrolment target: 150
Started: 12 June 2026
Main results due: 31 March 2029
Study sites: 19
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(19)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Arkansas Urology
Little Rock, Arkansas, United States
Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
Cedars Sinai Medical Center
Los Angeles, California, United States
Recruiting
Colorado Clinical Research
Lakewood, Colorado, United States
Recruiting
Florida Urology Partners
Wimauma, Florida, United States
Recruiting
Associated Urological Specialists
Chicago Ridge, Illinois, United States
Recruiting
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Recruiting
Michigan Institute of Urology
Troy, Michigan, United States
Recruiting
Specialty Clinical Research of St Louis
St Louis, Missouri, United States
Recruiting
SUNY Upstate Med Univ
Syracuse, New York, United States
Recruiting
Urology Specialists of the Carolinas PLLC Charlotte
Charlotte, North Carolina, United States
Recruiting
MidLantic Urology - Haverford Road - Bryn Mawr
Bryn Mawr, Pennsylvania, United States
Recruiting
Low Country Urology Clinics
North Charleston, South Carolina, United States
Recruiting
Urology Specialists of South Dakota
Sioux Falls, South Dakota, United States
Recruiting
UPNT Research Institute
Arlington, Texas, United States
Recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Recruiting
University of Washington School of Medicine
Seattle, Washington, United States
Recruiting
Spokane Urology
Spokane, Washington, United States
Recruiting

Showing 19 of 19 sites. 19 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07309445. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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