NCT03945162 · Theralase® Technologies Inc.
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
What this study is about
This is a phase II, where both patients and doctors know the treatment given, single-treatment group$1, multi-center Study conducted in Canada and the United States. 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.
View original scientific description
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. 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.
Interventions
COMBINATION_PRODUCT
Ruvidar® (TLD-1433) bladder infusion and PDT
Ruvidar® (TLD-1433) is infused into the bladder and treatment of bladder wall with PDT light activation using the TLC-3200 system.
Primary outcome measures
Efficacy, evaluated by Complete Response ("CR").
Time frame: Throughout Study II and up to the completion of the follow-up phase (15 month)
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 tract or prostatic urethra and random bladder biopsies are negative.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be willing and able to provide a written Informed Consent Form ("ICF") for the Study. 2. Be \> 18 years of age on day of signing ICF. 3. Have histologically confirmed NMIBC CIS via biopsy with/without resected papillary disease (Ta, T1) (high grade) using the 2004 World Health Organization ("WHO") / International Society of Urologic Pathology classification system. The most recent cystoscopy / TURBT must have been performed within 12 weeks of the Study Treatment date to confirm: histology, grade and stage. 4. 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. 5. Are not candidates for cystectomy on medical grounds or refuse radical cystectomy. 6. Have an Eastern Cooperative Onco
Where
- Chicago, Illinois
- Greenwood, Indiana
- Syracuse, New York
- Gahanna, Ohio
- Bala-Cynwyd, Pennsylvania
- Myrtle Beach, South Carolina
- Nashville, Tennessee
- San Antonio, Texas
- Richmond, Virginia
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2025 · Source of record for eligibility and locations