Real-world outcomes of TAR-200 for people with non-muscle invasive bladder cancer 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
This project will see if TAR-200 helps people with non-muscle invasive bladder cancer stay disease-free longer after their first insertion during routine care in the U.S.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT07309445 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with confirmed non-muscle invasive bladder cancer who have had their first TAR-200 insertion within six weeks in routine U.S. care, can provide informed consent, and will follow contraception guidance are the ideal candidates.
Not a fit: People who previously received TAR-200 in a clinical trial, had more than two prior TAR-200 doses in the real world, discontinued TAR-200 before baseline, or have a medical contraindication to TAR-200 are unlikely to benefit from joining.
Why it matters
Potential benefit: If successful, the study could clarify how TAR-200 performs in everyday clinical practice and inform treatment decisions for patients and clinicians.
How similar studies have performed: Early clinical studies and preliminary reports have shown promising anti-tumor activity for TAR-200 in NMIBC, but long-term real-world outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas
- Arkansas Urology — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.