Title
A Phase II Clinical Study of Intravesical Photodynamic Therapy in Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) or Patients Who Are Intolerant to BCG Therapy

Description
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada, the United States and internationally. Patients with NMIBC CIS with or without resected papillary disease (Ta, T1) that are considered bacillus Calmette-Guerin (BCG)-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; OR, At least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse less than 12 months after finishing the second course of BCG therapy are also considered BCG-Unresponsive. The Study will consist of 100 patients who will undergo two (2) PDT treatments employing 0.70 mg/cm^2 of TLD-1433 at Day 0 and Day 180.

Objective
Primary Objective: The primary endpoint of this Study is efficacy, evaluated by the Complete Response ("CR") rate at any time point in patients with Carcinoma In-Situ ("CIS") with resected papillary disease.
Patient CR is defined as at least one of the following: Negative cystoscopy and negative (including atypical) urine cytology, Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology, Negative cystoscopy with malignant urine cytology, if urothelial cancer is present in the upper tract or prostatic urethra and random bladder biopsies are negative.

Secondary Objective: Duration of CR at 12 months post initial CR.

Tertiary Objective: The tertiary endpoint of this Study is safety, evaluated by the incidence and severity of Adverse Events ("AEs"), Grade 4 or higher that do not resolve within 450 days post initial treatment; whereby: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening or disabling, Grade 5 = Death

Treatment Experimental: 0.7 mg/cm^2 TLD-1433 Bladder infusion and Photodynamic Therapy
A single instillation of TLD-1433 (at the therapeutic dose of 0.7 mg/cm^2) will be infused intravesically into the bladder for approximately 60 minutes. Photodynamic therapy treatment is performed after TLD1433 has been rinsed from the bladder. Two treatment procedures will be performed, a primary treatment at Day 0 and a secondary treatment at Day 180 post primary treatment.

Key Eligibility For full study eligibility, please see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Bladder

Participating Institutions
UW Health University Hospital