Clinical Trial

Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer

Study acronym: ADVANCED-3
Recruiting Phase 3
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Summary
The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older. The main questions it aims to answer are: * Can the study drug help participants with this type of cancer? * Is the study drug safe? * What are the side effects of the study drug? Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-30
notable Trial sites expanded: 0 -> 6 locations 2026-06-30
Trial Details
NCT Number NCT07480356
Lead Sponsor Protara Therapeutics
Conditions Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Enrollment 284 participants
Start Date 2026-05-29
Primary Completion 2028-04 (estimated)
Study Completion 2032-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-29