Phase II Study of Intravesical Ruvidar TLD-1433 and Photodynamic Therapy for Patients With BCG-Unresponsive or Intolerant Non-Muscle Invasive Bladder Cancer NMIBC Carcinoma In-Situ CIS

What this Trial Is About

Researchers are evaluating the use of a treatment called Ruvidarae TLD-1433 combined with photodynamic therapy PDT in patients who have Non-Muscle Invasive Bladder Cancer NMIBC with Carcinoma In-Situ CIS that is unresponsive or intolerant to Bacillus Calmette-Guerin BCG therapy. This phase II, open-label, single-arm study is conducted across multiple centers in Canada and the United States and includes patients with specific BCG treatment histories or intolerance. The study aims to assess the treatments ability to achieve a complete response in this patient population. Participants will receive one intravesical instillation of Ruvidarae TLD-1433 into the bladder, followed by photodynamic therapy using a specialized laser system called TLC-3200. The treatment involves a 60-minute infusion of Ruvidarae, rinsing, and light activation to the bladder wall. Based on patient response, up to two additional re-induction procedures may be administered. The study includes a screening period of up to 60 days to confirm eligibility. After treatment, patients will be followed for up to 15 months with regular assessments at specific intervals to monitor safety and efficacy, including cystoscopy and urine cytology. For those who achieve a complete or indeterminate response, survival and safety will be monitored for up to 36 months. The main outcome measured is the complete response rate, with additional evaluation of response duration and long-term observations. The study includes strict monitoring and data collection to assess treatment effects over time.

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients