OncoMatch/Clinical Trials/NCT03945162
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
Is NCT03945162 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ruvidar® (TLD-1433) bladder infusion and PDT for non-muscle invasive bladder cancer ("nmibc") unresponsive/intolerant to bcg.
Treatment: Ruvidar® (TLD-1433) bladder infusion and PDT — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS
Grade: high grade (2004 who/isup)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG
Intolerant to BCG or considered BCG-Unresponsive, which 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.
Cannot have received: intravesical chemotherapeutic agent
Exception: single perioperative dose of chemotherapy immediately post-TURBT (not considered treatment)
Prior treatment with an intravesical chemotherapeutic agent within 1 month of the first dose of current Study Drug, with the exception of a single perioperative dose of chemotherapy immediately post-TURBT (not considered treatment).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Site 02-012 - University of Chicago · Chicago, Illinois
- Site 02-016 - Urology of Indiana · Greenwood, Indiana
- Site 02-015 - Associated Medical Professionals of New York · Syracuse, New York
- Site 02-017 - Central Ohio Urology Group · Gahanna, Ohio
- Site 02-008 - MidLantic Urology · Bala-Cynwyd, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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