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RecruitingNCT07309445

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 Parameters

ConditionNon-Muscle Invasive Bladder Neoplasms
SponsorJanssen Research & Development, LLC
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment150
SexALL
Min Age18 Years
Max AgeN/A
Start Date2026-04-01
Completion2029-03-31

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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).

Eligibility Criteria

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

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