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Photodynamic therapy for patients with bladder cancer unresponsive to BCG treatment

A Phase II Clinical Study of Intravesical Ruvidar® in Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") or Patients Who Are Intolerant to BCG Therapy ("Study II")

Phase 2 Interventional Theralase® Technologies Inc. · NCT03945162

This study is testing a new light-based treatment for bladder cancer in patients who didn't respond to or couldn't tolerate the standard BCG therapy to see if it helps them.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorTheralase® Technologies Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations16 sites (Chicago, Illinois and 15 other locations)
Trial IDNCT03945162 on ClinicalTrials.gov

What this trial studies

This phase II, open-label, single-arm study evaluates the effectiveness of intravesical photodynamic therapy using Ruvidar® (TLD-1433) in patients with non-muscle invasive bladder cancer (NMIBC) who are either unresponsive or intolerant to Bacillus Calmette-Guerin (BCG) therapy. The study will enroll approximately 100 to 125 patients who will receive two treatments of PDT at specified intervals. Patients will be monitored for efficacy and safety over a follow-up period of 15 months, with assessments conducted at multiple time points. The goal is to determine the therapeutic potential of this novel treatment approach in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with histologically confirmed NMIBC CIS who are BCG-unresponsive or intolerant to BCG therapy.

Not a fit: Patients who are candidates for cystectomy or have other medical conditions that preclude participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with NMIBC who have limited alternatives due to BCG unresponsiveness or intolerance.

How similar studies have performed: While the approach of using photodynamic therapy is being explored, this specific application in BCG-unresponsive NMIBC is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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 Procedure 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 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.

Exclusion Criteria:

1. Past or current muscle invasive (i.e.: T2, T3, T4) or metastatic urothelial carcinoma.
2. Has concurrent extravesical (i.e.: urethra, ureter, renal pelvis, prostate or prostatic ducts) non-muscle invasive transitional cell carcinoma of the urothelium. (confirmed by staging to exclude extravesical disease, which may include radiological imaging and/or biopsy) within 3 months of enrollment:

   If previous work up occurred more than 3 months prior to enrollment, staging for extravesical disease must be repeated prior to enrolment in order to determine eligibility.
3. Active gross hematuria.
4. Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer or localized prostate cancer under active surveillance with Gleason 6 disease. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower Prostate-Specific Antigen ("PSA") undetectable for 2 years while off androgen deprivation therapy or no more than 2 consecutive rising PSAs.
5. Have a history or current evidence of any condition, therapy, surgery or laboratory abnormality that, in the opinion of the PI, might confound the results of the study, interfere with the patient's participation in the study, or is not in the best interest of the patient to participate.
6. Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications).
7. Participated in a study with an investigational agent or device within 1 month from the first dose of current Study Procedure.
8. 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).
9. Have an active infection requiring systemic therapy, including active or intractable Urinary Tract Infection ("UTI"), not resolved prior to the procedure.
10. Has any contraindication to general or spinal anesthesia.
11. Is pregnant or breastfeeding within the projected duration of Study II, starting with the screening visit through to two weeks following the last Study Procedure.

Where this trial is running

Chicago, Illinois and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Muscle Invasive Bladder Cancer Unresponsive/Intolerant to BCGPhotodynamic TherapyNon-muscle invasive bladder cancerUrothelial carcinomaTa bladder cancerT1 bladder cancerUnresponsive/Intolerant to BCG
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.