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

Conditions

• Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruvidar® (TLD-1433) bladder infusion and PDT — COMBINATION_PRODUCT
  Ruvidar® (TLD-1433) is infused into the bladder and treatment of bladder wall with PDT light activation using the TLC-3200 system.

Study Details

This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("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 within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.

Key Dates

Start date

Aug 30, 2019

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

90 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 0.70 mg/cm^2 Ruvidar® (TLD-1433) Bladder instillation and Photodynamic Therapy
  Each Study Procedure is a single instillation of Ruvidar® (TLD-1433) (at the therapeutic dose of 0.70 mg/cm\^2) will be infused intravesically into the bladder for approximately 60 minutes, followed by PDT treatment using the TLC-3200 system, which is performed after Ruvidar® (TLD-1433) has been rinsed from the bladder. One Study Procedure will be performed, with up to 2 additional re-induction Study Procedures based on patient response.

Primary Outcome Measure

Efficacy, evaluated by Complete Response ("CR"). [ Time Frame: Throughout Study II and up to the completion of the follow-up phase (15 month) ]

Central Contacts

• Arkady Mandel, MD, PhD, DSc
  416-699-5273
  [email protected]

Locations (10)

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