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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

RecruitingObservational study

A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US

Who can join

Ages 18 and older · All sexes

Full 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 trial

About the study

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).

Sponsor: Janssen Research & Development, LLC · Participants: 150 · Started: Jun 12, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07309445

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ArkansasArkansas Urology, Little Rock
CaliforniaCedars Sinai Medical Center, Los Angeles
USC Norris Comprehensive Cancer Center, Los Angeles
ColoradoColorado Clinical Research, Lakewood
FloridaFlorida Urology Partners, Wimauma
IllinoisAssociated Urological Specialists, Chicago Ridge
IndianaIndiana University Melvin and Bren Simon Cancer Center, Indianapolis
MichiganMichigan Institute of Urology, Troy
MissouriSpecialty Clinical Research of St Louis, St Louis
New YorkSUNY Upstate Med Univ, Syracuse
North CarolinaUrology Specialists of the Carolinas PLLC Charlotte, Charlotte
PennsylvaniaMidLantic Urology - Haverford Road - Bryn Mawr, Bryn Mawr
South CarolinaLow Country Urology Clinics, North Charleston
South DakotaUrology Specialists of South Dakota, Sioux Falls
TexasUPNT Research Institute, Arlington
UT Southwestern Medical Center, Dallas
WashingtonUniversity of Washington School of Medicine, Seattle
Spokane Urology, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.