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 now

Conditions studied: Non-Muscle Invasive Bladder Neoplasms

In brief

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 facts

Study ID

NCT07309445

Run by

Janssen Research & Development, LLC

People needed

150

Starts

2026-06-12

Expected to finish

2029-10-09

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Colorado Clinical Research — Lakewood, Colorado, United States (enrolling)
• Florida Urology Partners — Wimauma, Florida, United States (enrolling)
• Associated Urological Specialists — Chicago Ridge, Illinois, United States (enrolling)
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Michigan Institute of Urology — Troy, Michigan, United States (enrolling)
• Specialty Clinical Research of St Louis — St Louis, Missouri, United States (enrolling)
• SUNY Upstate Med Univ — Syracuse, New York, United States (enrolling)
• Urology Specialists of the Carolinas PLLC Charlotte — Charlotte, North Carolina, United States (enrolling)
• Low Country Urology Clinics — North Charleston, South Carolina, United States (enrolling)
• Urology Specialists of South Dakota — Sioux Falls, South Dakota, United States (enrolling)
• UPNT Research Institute — Arlington, Texas, United States (enrolling)
• Spokane Urology — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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