BridgeMD
A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator’s Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred with High-risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
EU CTIS ID: 2023-507685-10-00
What this study is testing
To compare disease-free survival (DFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only HR-NMIBC (defined as HG Ta or any T1, no CIS).
- Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded.
- All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for HG UC before randomization. For participants with lamina propria invasion (T1) on the Screening biopsy/TURBT, muscularis propria must be present to rule out MIBC.
- Participants must have received at least 5 of 6 induction doses of BCG (adequate induction) with or without maintenance therapy.
- Diagnosis of recurrent, papillary-only HR-NMIBC (defined as HG Ta or any T1, no CIS) must be within 12 months of the last dose of BCG therapy.
- Participants must be ineligible for or have elected not to undergo RC.
You likely can't join if
- Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic UC (ie, T2, T3, T4, N+, and/or M+).
- Must not currently have UC or histological variant at any site outside of the urinary bladder. UC of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization with no evidence of recurrence.
- N+ and/or M+ per BICR of CT/MR Urography.
- Received serial intravesical therapy or systemic therapy from the time of histologic diagnosis of recurrent HR-NMIBC to date of randomization. Immediate post-TURBT single-dose per-operative intravesical chemotherapy is allowed in accordance with institutional guidelines.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Argentina
- Japan
- Korea, Republic of
- Brazil
- China
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Argentina; Japan; Korea, Republic of; Brazil; China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.