Recruiting

TAR-200

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07309445

Conditions

Non-Muscle Invasive Bladder Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Non-Muscle Invasive Bladder Neoplasms

Study ID

NCT07309445

Start date

Jun 12, 2026

Status verified date

Aug, 2026

Completion date

Oct 9, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

NMIBC Participants: Routine Clinical Practice Setting

Participants with confirmed diagnosis of NMIBC and who have initiated first dose of TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200, or until the participant dies, is lost to follow-up, or withdraws consent in the study. No intervention will be administered as a part of this study.

Primary outcome measure

  • Disease-Free Survival (DFS) [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Eliza M. Raymundo, MD, DMCC, FPUA, FPCS

1-669-800-7705

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

Florida Urology Partners

Recruiting

Wimauma, Florida, United States, 33598

Associated Urological Specialists

Recruiting

Chicago Ridge, Illinois, United States, 60415

Indiana University Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Michigan Institute of Urology

Recruiting

Troy, Michigan, United States, 48084

Specialty Clinical Research of St Louis

Recruiting

St Louis, Missouri, United States, 63141

SUNY Upstate Med Univ

Recruiting

Syracuse, New York, United States, 13210

Urology Specialists of the Carolinas PLLC Charlotte

Recruiting

Charlotte, North Carolina, United States, 28204

Low Country Urology Clinics

Recruiting

North Charleston, South Carolina, United States, 29406

Urology Specialists of South Dakota

Recruiting

Sioux Falls, South Dakota, United States, 57108

UPNT Research Institute

Recruiting

Arlington, Texas, United States, 76017

University of Washington School of Medicine

Recruiting

Seattle, Washington, United States, 98195

Spokane Urology

Recruiting

Spokane, Washington, United States, 99202

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.