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

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 si

Trial Details

NCT ID
NCT03945162
Phase
PHASE2
Sponsor
Theralase® Technologies Inc.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Ruvidar® (TLD-1433) bladder infusion and PDT
Locations (sample)
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Greenwood, Indiana, United States|39.61366,-86.10665
  • Syracuse, New York, United States|43.04812,-76.14742
  • Gahanna, Ohio, United States|40.01923,-82.87934
  • Bala-Cynwyd, Pennsylvania, United States|40.00761,-75.23407

Key Eligibility Criteria

  • Be willing and able to provide a written Informed Consent Form ("ICF") for the Study.
  • Be \> 18 years of age on day of signing ICF.
  • Have histologically confirmed NMIBC CIS via biopsy with/without resected papillary disease (Ta, T1) (high grade) using the 2004 World Health Organi…
  • Intolerant to BCG or considered BCG-Unresponsive, which is at least one of the following:

For full eligibility, visit ClinicalTrials.gov.

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