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 (Nova-sTAR)

Janssen (J&J Innovative Medicine)

Status: Not yet enrolling

Conditions: Non-Muscle Invasive Bladder Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT07309445

17000139BLC4004 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

NMIBC Participants: Routine Clinical Practice Setting

Description:

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.