Phase II International Study of Intravesical T3011 Injection for Treating High-Risk Non-Muscle-Invasive Bladder Cancer Unresponsive to BCG or Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intravesical T3011 injection in adults with high-risk non-muscle invasive bladder cancer NMIBC that has not responded to BCG treatment or chemotherapy. This Phase II study includes participants with different types of NMIBC, such as carcinoma in situ CIS and papillary tumors, who have either failed BCG therapy or chemotherapy after BCG exposure. Participants receive T3011 treatment directly into the bladder once a week for six weeks during the induction phase. Based on their response at three months, some may receive a reinduction course. Those who show complete response or no recurrence enter a maintenance phase with T3011 administered every three weeks for up to about 24 months. Disease status is regularly monitored through cystoscopy, urine cytology, histopathology, and imaging every three months during treatment or until recurrence. Throughout the study, participants undergo assessments including tumor evaluations and safety monitoring for treatment-related side effects. The primary outcomes measured include complete response rates, recurrence-free survival at various time points, and the incidence of significant treatment-related adverse events over 24 months. Participants are followed closely to assess both effectiveness and safety of the treatment during the entire study period.

A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC