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NCT03945162 · ClinicalTrials.gov registry record · Phase 2
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
A Phase 2 study of Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG, sponsored by Theralase® Technologies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 16
- Study locations
NCT03945162: Recruiting Phase 2 study of Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG, sponsored by Theralase® Technologies.
NCT03945162 is a Phase 2 study of Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG that is actively recruiting participants, run by Theralase® Technologies. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 16 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03945162, a Phase 2 study of Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG, is actively recruiting participants, sponsored by Theralase® Technologies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 16
- Study locations
Study Summary
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.
Primary Outcome
The primary endpoint of Study II is efficacy, evaluated by the Complete Response ("CR") 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 suspected in the upper
Conditions Studied
Interventions
- COMBINATION_PRODUCT Ruvidar® (TLD-1433) bladder infusion and PDT
Study Locations (16)
Ontario
- Site 01-014 - St. Joseph's Healthcare - Hamilton
- Site 01-002- London Health Sciences Centre - Victoria Hospital - London
- Site 01-001 - University Health Network - Princess Margaret Cancer Centre - Toronto
Illinois
- Site 02-012 - University of Chicago - Chicago
Indiana
- Site 02-016 - Urology of Indiana - Greenwood
New York
- Site 02-015 - Associated Medical Professionals of New York - Syracuse
Ohio
- Site 02-017 - Central Ohio Urology Group - Gahanna
Pennsylvania
- Site 02-008 - MidLantic Urology - Bala-Cynwyd
South Carolina
- Site 02-006 - Carolina Urologic Research Center - Myrtle Beach
Tennessee
- Site 02-007 - Urology Associates, P. C - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-08-30 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT03945162 shows while recruiting
NCT03945162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG appearing as the primary indexed condition, and to 1 intervention - of which Ruvidar® (TLD-1433) bladder infusion and PDT is the first listed.
NCT03945162 lists 16 locations in 14 states (Ontario, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT03945162 about?
NCT03945162 is a clinical study titled "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")-Un...
What is the current status of trial NCT03945162?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2019-08-30. Estimated completion is 2027-12.
What conditions does trial NCT03945162 study?
This clinical trial studies the following conditions: Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG.
What interventions are being tested in trial NCT03945162?
The interventions under investigation include: Ruvidar® (TLD-1433) bladder infusion and PDT (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03945162?
This trial is sponsored by Theralase® Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03945162 being conducted?
This trial has 16 study locations across Illinois, Indiana, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03945162's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,200 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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