Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
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ClinicalTrials.gov Identifier: NCT03945162 |
Recruitment Status :
Recruiting
First Posted : May 10, 2019
Last Update Posted : May 1, 2023
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Condition or disease | Intervention/treatment | Phase |
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Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG | Combination Product: Ruvidar® (TLD-1433) Bladder infusion and PDT | Phase 2 |

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 |

Arm | Intervention/treatment |
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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.
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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. |
- 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.
- 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.
- 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

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be willing and able to provide a written Informed Consent Form ("ICF") for the Study.
- Be > 18 years of age on day of signing ICF.
- 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.
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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.
- Are not candidates for cystectomy on medical grounds or refuse radical cystectomy.
- Have an Eastern Cooperative Oncology Group ("ECOG") performance score of 0 to 2.
- Have satisfactory bladder function. Ability to retain Study Drug for a minimum of 60 minutes.
- Are available for the duration of the Study including follow-up (approximately 15 months).
- 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.
- 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:
- Past or current muscle invasive (i.e.: T2, T3, T4) or metastatic urothelial carcinoma.
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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.
- Active gross hematuria.
- 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.
- 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.
- Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications).
- Participated in a study with an investigational agent or device within 1 month from the first dose of current Study treatment.
- 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).
- Have an active infection requiring systemic therapy, including active or intractable Urinary Tract Infection ("UTI"), not resolved prior to the procedure.
- Has any contraindication to general or spinal anesthesia.
- 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.

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
Contact: Arkady Mandel, MD, PhD, DSc | 416-699-5273 ext 242 | amandel@theralase.com |
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 |
Principal Investigator: | Girish Kulkarni, MD, FRCSC | University Health Network, Toronto |
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 |
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 |
Photodynamic Therapy Non-muscle invasive bladder cancer ("NMIBC") Urothelial carcinoma |
Ta bladder cancer T1 bladder cancer Unresponsive/Intolerant to BCG |
Urinary Bladder Neoplasms Non-Muscle Invasive Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |