Actively Recruiting
A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
150
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how the treatment TAR-200 performs in real-world settings for people with non-muscle invasive bladder cancer (NMIBC), an early-stage bladder cancer limited to the bladder lining. The study aims to measure the time from the first TAR-200 insertion until the cancer worsens or symptoms return, called disease-free survival. This observational study is led by Janssen Research & Development, LLC and takes place across multiple centers in the United States. Participants who have a confirmed NMIBC diagnosis and started their first dose of TAR-200 within six weeks before the study's baseline visit will be observed without additional study interventions. They will be followed for up to 24 months from the start of TAR-200 treatment, or until death, loss to follow-up, or withdrawal from the study. No new treatments or placebo are given as part of this study. During the study, researchers will monitor various outcomes including disease-free survival, complete response rates, duration of response, overall survival, cancer-specific survival, and treatment patterns for TAR-200 over 24 months. They will also track adverse events, time to next treatment, and bladder preservation rates. Participants will be regularly followed to assess these measures, and adherence to treatment will be supported with follow-up reminders. The study provides long-term observational data on how TAR-200 is used and its effects in routine practice.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of non-muscle invasive bladder cancer based on TURBT or cold cup biopsy
- Initiated first dose of TAR-200 within 6 weeks prior to baseline visit
- Participants with childbearing potential must follow contraceptive guidelines in TAR-200 product labeling and consult their physician
- Must provide informed consent as described in the protocol
You will not qualify if you...
- Any medical condition deemed by healthcare practitioner as contraindicated for TAR-200 treatment
- Previous TAR-200 treatment discontinued before baseline visit
- Prior TAR-200 use as part of a clinical trial
- Received more than 2 doses/cycles of TAR-200 in real-world setting
- Currently enrolled in an interventional bladder cancer clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who have started TAR-200 treatment in routine clinical practice are observed for outcomes related to non-muscle invasive bladder cancer.
Visits occur during routine clinical practice over 24 months
Trial Site Locations
Total: 1 location
1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
Research Team
S
Study Contact
E
Eliza M. Raymundo, MD, DMCC, FPUA, FPCS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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