Phase 3 Study Comparing Intravesical TARA-002 and Chemotherapy for Treating High-Grade Non-Muscle Invasive Bladder Cancer in BCG-Naive Adults

What this Trial Is About

Researchers are evaluating the drug TARA-002 for treating high-grade non-muscle invasive bladder cancer NMIBC in adults aged 18 years and older who have not previously received BCG therapy. The main goals are to determine if TARA-002 can help treat this cancer type, assess its safety, and identify any side effects. The study compares TARA-002 with investigators choice of intravesical chemotherapy to see how well each treatment works. Participants will be randomly assigned to receive either TARA-002 or an intravesical chemotherapy selected by their investigator. Those receiving TARA-002 will get six weekly doses initially, with the possibility of additional maintenance and reinduction treatments based on their response at weeks 12 and 24. Participants in the chemotherapy group will receive six weekly doses followed by monthly maintenance doses up to month 25. These treatments are administered directly into the bladder. During the study, participants undergo regular assessments to measure cancer response, including the rate of complete response at six months and ongoing evaluations up to five years. Researchers will monitor treatment-related side effects and track survival outcomes, recurrence, progression, and time to bladder removal surgery. The study lasts until November 2032, with primary outcomes measured at six months and extended follow-up continuing for up to 60 months.

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