Kapitanivka

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.

Researchers are studying the safety and effectiveness of TARA-002, a biological preparation containing Streptococcus pyogenes cells, for adults aged 18 and older with high-grade non-muscle invasive bladder cancer NMIBC, including carcinoma in situ CIS with or without TaT1 tumors. This Phase 2 open-label trial further evaluates TARA-002 at a dose established in an earlier Phase 1a study. Participants include those with active disease confirmed within 3 months before enrollment, divided into two groups based on prior treatment with BCG therapy. Participants receive TARA-002 directly into the bladder through instillation. The treatment involves an initial period of six weekly doses, followed by a possible second period of six additional weekly doses or three weekly maintenance doses for those with a complete response. Maintenance doses continue at specified months up to 24 months. After treatment, participants enter a follow-up period lasting from month 27 to month 60 to monitor long-term outcomes. Throughout the study, participants undergo regular assessments including evaluations of tumor response, progression-free survival, overall survival, and quality of life using specific questionnaires. Researchers monitor urinary biomarkers and track adverse events from the first day of treatment through the entire follow-up period. The studys main outcome is the rate of high-grade complete response measured from 3 to 60 months after treatment. Total participation may last up to 5 years.