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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 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
18 years and older
All
Phase N/A

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Overview

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

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 details
    Non-Muscle Invasive Bladder Neoplasms

NCT07309445

Janssen Research & Development, LLC

13 May 2026

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