Real-world outcomes of TAR-200 for people with non-muscle invasive bladder cancer in the United States

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, real-world study that follows people with confirmed non-muscle invasive bladder cancer who have recently started TAR-200. The main measure is disease-free survival, defined as the time from the first TAR-200 insertion to cancer worsening or recurrence. Eligible participants must have a diagnosis confirmed by TURBT or cold cup biopsy and must have begun their first TAR-200 dose within six weeks before the baseline visit, while those with prior TAR-200 in trials, more than two prior real-world doses, or contraindications are excluded. The study collects clinical outcomes and safety information from routine care visits without assigning additional interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic 1
  Phoenix, Arizona, United States Recruiting
• Arkansas Urology
  Little Rock, Arkansas, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Colorado Clinical Research
  Lakewood, Colorado, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TAR-210 versus intravesical chemotherapy for high-risk non-muscle-invasive bladder cancer

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• Comparing TAR-210 to standard chemotherapy for bladder cancer treatment

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• Tracking quality of life and relapses in bladder cancer patients after surgery

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• NMIBC sample collection to test cancer monitoring biomarkers

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  Recruiting Natera, Inc. · Austin, Texas · NCT07763197

• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

  Recruiting Phase 2 Blokhin's Russian Cancer Research Center · Moscow, Moscow · NCT07747740

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.