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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

NCT ID: NCT07309445

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-18

Study Completion Date

2029-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Non-Muscle Invasive Bladder Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

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

Role: CONTACT

Phone: 1-669-800-7705

Email: [email protected]

Other Identifiers

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17000139BLC4004

Identifier Type: OTHER

Identifier Source: secondary_id

17000139BLC4004

Identifier Type: -

Identifier Source: org_study_id