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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

150 Participants
are grouped into 1 trial group