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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03945162
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 1, 2023
Information provided by (Responsible Party):
Theralase® Technologies Inc.

Brief Summary:
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. 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 approximately 100 to 125 patients who will undergo two (2) PDT treatments employing 0.70 mg/cm^2 of Ruvidar® (TLD-1433) at Day 0 and Day 180.

Condition or disease Intervention/treatment Phase
Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG Combination Product: Ruvidar® (TLD-1433) Bladder infusion and PDT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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")
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: 0.7 mg/cm^2 Ruvidar® (TLD-1433) Bladder infusion and Photodynamic Therapy
A single instillation of Ruvidar® (TLD-1433) (at the therapeutic dose of 0.7 mg/cm^2) will be infused intravesically into the bladder for approximately 60 minutes. PDT treatment is performed after Ruvidar® (TLD-1433) has been rinsed from the bladder. Two Study Treatments will be performed, a primary Study Treatment at Day 0 and a maintenance Study Treatment at Day 180.
Combination Product: Ruvidar® (TLD-1433) Bladder infusion and PDT
Ruvidar® (TLD-1433) is infused into the bladder and treatment of bladder wall with light activation.

Primary Outcome Measures :
  1. 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 present in the upper tract or prostatic urethra and random bladder biopsies are negative.

Secondary Outcome Measures :
  1. Efficacy, evaluated by the duration of CR [ Time Frame: Throughout study II and up to the completion of the follow-up phase (15 month) ]
    Duration of CR at 12 months post initial CR.

Other Outcome Measures:
  1. Safety, evaluated by the incidence and severity of Adverse Events. [ Time Frame: Throughout the study and up to the completion of the follow-up phase (15 month) ]
    The tertiary endpoint of Study II is safety, evaluated by the incidence and severity of Adverse Events ("AEs"), Grade 4 or higher that do not resolve within 450 days post initial treatment; whereby: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening or disabling, Grade 5 = Death

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 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 Treatment.
  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 Treatment. 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 treatment.
  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 second Ruvidar® (TLD-1433) instillation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945162

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Contact: Arkady Mandel, MD, PhD, DSc 416-699-5273 ext 242 amandel@theralase.com

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United States, Illinois
Site 02-012 - University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Megan Mendez    773-702-1835    Megan.Mendez@medicine.bsd.uchicago.edu   
Principal Investigator: Piyush Agarwal, MD         
United States, Pennsylvania
Site 02-008 - MidLantic Urology Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19087
Contact: Cheryl Zinar    610-632-4137    czinar@midlanticurology.com   
Principal Investigator: Laurence Belkoff, MD         
United States, South Carolina
Site 02-006 - Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Sutton    843-449-1010 ext 316    jsutton@curcmb.com   
Principal Investigator: Dr. Neal Shore, MD         
United States, Tennessee
Site 02-007 - Urology Associates, P. C Recruiting
Nashville, Tennessee, United States, 37209
Contact: Micki Porcello    615-250-9282    MLPorcello@ua-pc.com   
Principal Investigator: Dr. Gautam Jayram         
United States, Texas
Site 02-010 - Urology San Antonio P. A Recruiting
San Antonio, Texas, United States, 78229
Contact: Sandra Salas    210-617-4116 ext 1617    sandra.salas@urologysa.com   
Principal Investigator: Daniel Saltzstein, MD         
United States, Virginia
Site 02-009 - Virginia Urology Terminated
Richmond, Virginia, United States, 23235
United States, Wisconsin
Site 02-011 - University of Wisconsin Health University Hospital Recruiting
Madison, Wisconsin, United States, 53792
Contact: Abigail Wiedmer    608-265-9172    wiedmer@urology.wisc.edu   
Principal Investigator: Dr. Kyle Richards, MD         
Canada, British Columbia
Site 01-005 - The Vancouver Prostate Centre - Diamond Health Care Centre - Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Genevive Moreau    604-875-4111 ext 67898    gbaloloy@prostatecentre.com   
Principal Investigator: Peter Black, MD         
Canada, Nova Scotia
Site 01-004 - Nova Scotia Health Authority - Centre for Applied Urology Research Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Robin Simpson    902-473-7969    Robin.simpson@nshealth.ca   
Principal Investigator: Ricardo Rendon, M.D.         
Canada, Ontario
Site 01-002- London Health Sciences Centre - Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Wendy Shoff    519-685-8500 ext 57350    wendy.shoff@lhsc.on.ca   
Principal Investigator: Jonathan Izawa, MD         
Site 01-001 - University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Sarah Cheung    437-335-2949    sarah.cheung@uhn.ca   
Principal Investigator: Girish Kulkarni, MD         
Canada, Quebec
Site 01-003 - McGill University Health Centre - Glen-Cedars Cancer Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Rodrigo Skowronski    514-934-1934 ext 64222    rodrigo.skowronski@muhc.mcgill.ca   
Principal Investigator: Wassim Kassouf, MD         
Sponsors and Collaborators
Theralase® Technologies Inc.
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Principal Investigator: Girish Kulkarni, MD, FRCSC University Health Network, Toronto
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Responsible Party: Theralase® Technologies Inc.
ClinicalTrials.gov Identifier: NCT03945162    
Other Study ID Numbers: Ruvidar® (TLD-1433) NMIBC PDT
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Theralase® Technologies Inc.:
Photodynamic Therapy
Non-muscle invasive bladder cancer ("NMIBC")
Urothelial carcinoma
Ta bladder cancer
T1 bladder cancer
Unresponsive/Intolerant to BCG
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type