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NCT07309445Recruiting

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

Janssen Research & Development, LLC

Start Date

6/12/2026

Completion Date

10/9/2029

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interested in This Trial?

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Conditions

Non-Muscle Invasive Bladder Neoplasms

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Arkansas Urology

Little Rock, Arkansas 72211

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Colorado Clinical Research

Lakewood, Colorado 80228

United States

Florida Urology Partners

Wimauma, Florida 33598

United States

Associated Urological Specialists

Chicago Ridge, Illinois 60415

United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

Michigan Institute of Urology

Troy, Michigan 48084

United States

Specialty Clinical Research of St Louis

St Louis, Missouri 63141

United States

SUNY Upstate Med Univ

Syracuse, New York 13210

United States

Urology Specialists of the Carolinas PLLC Charlotte

Charlotte, North Carolina 28204

United States

Low Country Urology Clinics

North Charleston, South Carolina 29406

United States

Urology Specialists of South Dakota

Sioux Falls, South Dakota 57108

United States

UPNT Research Institute

Arlington, Texas 76017

United States

Spokane Urology

Spokane, Washington 99202

United States