Clinical trial · Observational
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Muscle Invasive Bladder Neoplasms | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- NMIBC Participants: Routine Clinical Practice Setting
- description
- Participants with confirmed diagnosis of NMIBC and who have initiated first dose of TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200, or until the participant dies, is lost to follow-up, or withdraws consent in the study. No intervention will be administered as a part of this study.
Primary outcomes (1)
- measure
- Disease-Free Survival (DFS)
- timeFrame
- Up to 24 months
- description
- DFS is defined as the time from first TAR-200 initiation date to the time of the first recurrence of NMIBC (Ta, any T1 or carcinoma in-situ \[CIS)\], progression (to muscle invasive bladder cancer \[MIBC; T greater than or equal to {\>=} 2\] or to lymph node \[N+\] or to distant disease \[M+\], whichever occurs first), or death due NMIBC, whichever occurs first.
Secondary outcomes (20)
- measure
- Complete Response (CR) Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available