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Photodynamic Therapy for BCG-Unresponsive Bladder Cancer

This study is testing a treatment called photodynamic therapy (PDT) for non-muscle invasive bladder cancer (NMIBC) that has not responded to or tolerated standard BCG therapy. The treatment involves infusing Ruvidar® (TLD-1433) into the bladder, followed by light activation using the TLC-3200 system. Researchers want to see how many patients achieve a complete response (meaning their cancer disappears) throughout the study and up to 15 months later. You might be able to join if you are over 18, have NMIBC Carcinoma In-Situ (CIS) confirmed by biopsy, and your cancer is considered unresponsive or intolerant to BCG. This study plans to enroll 90 participants, but its current status is unclear.

Study design
This is a Phase II, open-label, single-arm study, meaning all 90 participants will receive the same treatment and everyone involved will know what treatment is being given. It is being conducted at multiple centers in Canada and the United States.
What's involved
Participants will undergo a screening period of up to 60 days. If eligible, you will receive one study procedure, with the possibility of up to two additional treatments based on your response.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and efficacy assessments for 15 months after their primary study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03945162

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Theralase® Technologies Inc.
~90 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Ruvidar® (TLD-1433) bladder infusion and PDT

At a glance

Recruiting sites
13 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy, evaluated by Complete Response ("CR").
Measured over Throughout Study II and up to the completion of the follow-up phase (15 month)

Conditions

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

Explore related trials

Non-Muscle Invasive Bladder CarcinomaUrothelial Carcinoma

Where it's being run

16 sites across 14 states
Ontario3
Illinois1
Indiana1
New York1
Ohio1
Pennsylvania1
South Carolina1
Tennessee1

Study leadership

  • Girish Kulkarni, MD, FRCSC · PRINCIPAL_INVESTIGATOR · University Health Network, Toronto

Who to contact

Arkady Mandel, MD, PhD, DSc
[email protected]
416-699-5273 · ext. 242
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 Oncology Group ("ECOG") performance score of 0 to 2. 7. Have satisfactory bladder function. Ability to retain Study Drug for a minimum of 60 minutes. 8. Are available for the duration of the Study including follow-up (approximately 15 months). 9. Female patients of childbearing potential must have a negative Human Chorionic Gonadotropin ("HCG") pregnancy test taken during the screening visit and confirmed prior to the Study Procedure. 10. Female patients of childbearing potential must be willing to use 2 methods of birth control (i.e.: oral contraceptive, pills, diaphragm or condoms) or be surgically sterile, or abstain from heterosexual activity for two weeks after the Study Procedure. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year.

What this trial measures

  • Efficacy, evaluated by Complete Response ("CR").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.