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NCT07309445Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
16 Dec 2025
Start date
12 Jun 2026
Primary completion date
31 Mar 2029
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT07309445

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 12 Jun 2026 to the primary completion date, 31 Mar 2029
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior 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

Other illness

  • Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
  • Currently participating in an interventional bladder cancer clinical trial

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UPNT Research Institute
Coordinator of this site? Confirm its status
ArlingtonUnited StatesRecruiting
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
MidLantic Urology - Haverford Road - Bryn Mawr
Coordinator of this site? Confirm its status
Bryn MawrUnited StatesRecruiting
Urology Specialists of the Carolinas PLLC Charlotte
Coordinator of this site? Confirm its status
CharlotteUnited StatesRecruiting
Associated Urological Specialists
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Chicago RidgeUnited StatesRecruiting
UT Southwestern Medical Center
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DallasUnited StatesRecruiting
Frederick Health
Coordinator of this site? Confirm its status
FrederickUnited StatesRecruiting
Indiana University/Melvin and Bren Simon Cancer Center
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Colorado Clinical Research
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LakewoodUnited StatesRecruiting
Arkansas Urology
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Little RockUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Low Country Urology Clinics
Coordinator of this site? Confirm its status
North CharlestonUnited StatesRecruiting
Mayo Clinic 1
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PhoenixUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
University of Washington School of Medicine
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SeattleUnited StatesRecruiting
Urology Specialists of South Dakota
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Sioux FallsUnited StatesRecruiting
Spokane Urology
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SpokaneUnited StatesRecruiting
Specialty Clinical Research of St. Louis
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St LouisUnited StatesRecruiting
SUNY Upstate Med Univ
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SyracuseUnited StatesRecruiting
Michigan Institute of Urology
Coordinator of this site? Confirm its status
TroyUnited StatesRecruiting
Florida Urology Partners
Coordinator of this site? Confirm its status
WimaumaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.