gemcitabine-releasing intravesical system
gemcitabine-releasing intravesical system: 6 clinical trials tracked.
gemcitabine-releasing intravesical system evidence translation
What we can confirm
6 tracked trials
What it means
What to watch
Prepared research question
What is verified about gemcitabine-releasing intravesical system, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Clinical Trial Registry Records (6)
Pre-Approval Access US Intermediate Size Expanded Access Protocol for TAR-200 Treating Physician Use
17000139BLC3004: 17000139BLC3004 [SunRISe-5] Ph III HR NMIBC BCG Exp/UR Pap (N=250)
Primary endpoint: Disease-free Survival (DFS)
A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
Primary endpoint: Event-free Survival (EFS)
A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
Primary endpoint: Pathologic Complete Response (pCR) Rate
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Primary endpoint: Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy
Primary endpoint: Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event