Intravesical Photodynamic Therapy (PDT) in BCG Refractory/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 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG | Combination Product: TLD-1433 Bladder infusion and Photodynamic Therapy | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 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 Photodynamic Therapy in Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Or Patients Who Are Intolerant to BCG Therapy ("Study"). |
Actual Study Start Date : | August 30, 2019 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | May 2023 |

Arm | Intervention/treatment |
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Experimental: 0.7 mg/cm^2 TLD-1433 Bladder infusion and Photodynamic Therapy
A single instillation of TLD-1433 (at the therapeutic dose of 0.7 mg/cm^2) will be infused intravesically into the bladder for approximately 60 minutes. Photodynamic therapy treatment is performed after TLD1433 has been rinsed from the bladder. Two treatment procedures will be performed, a primary treatment at Day 0 and a secondary treatment at Day 180 post primary treatment.
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Combination Product: TLD-1433 Bladder infusion and Photodynamic Therapy
TLD1433 is infused into the bladder, followed by repeated rinsing and treatment of bladder wall with photodynamic therapy (PDT).
Other Name: PDT |
- Efficacy, evaluated by the Complete Response (CR) rate. [ Time Frame: Throughout the study and up to the completion of the follow-up phase (15 month) ]
The primary endpoint of this Study is efficacy, evaluated by the Complete Response ("CR") rate in patients with Carcinoma In-Situ ("CIS") with or without resected papillary disease at 360 days post primary treatment. 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 cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
For patients who are lost to follow-up or withdraw from the Study before recurrence or death, the CR will be censored at last disease assessment; for patients who start new anti- cancer treatment (i.e.: chemotherapy, immunotherapy or radiotherapy) or undergo a cystectomy, the CR will be censored at the last disease assessment before the start of the new anti-cancer therapy or cystectomy.
- 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) ]AE summaries will be provided showing the number and percentage of patients who experienced at least 1 AE. These summaries will be presented by body system and preferred term. AEs resulting in discontinuation will be summarized separately. Adverse Events (AEs) will be monitored from the time of signing the Informed Consent Form (ICF) until End of Study. The relationship of every AEs to the study drug will be determined and documented by the principal investigator whether considered treatment-related, and classified as related, unlikely, possibly, or probably related. All AEs should be treated appropriately. All AEs will be followed until resolution or stabilization or until End of Study (whichever comes first). The severity of each AE will be evaluated as mild, moderate, or severe.

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 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 1 hour.
- 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 the Study, starting with the screening visit through to two weeks following the second 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, Ph.D | 416-699-5273 ext 242 | amandel@theralase.com |
United States, Pennsylvania | |
Site 02008 - MidLantic Urology | Recruiting |
Bala-Cynwyd, Pennsylvania, United States, 19087 | |
Contact: Cheryl Zinar 610-667-0458 czinar@ucsepa.com | |
Principal Investigator: Dr. Laurence Belkoff, MD | |
United States, South Carolina | |
Site 02006 - Carolina Urologic Research Center | Recruiting |
Myrtle Beach, South Carolina, United States, 29572 | |
Contact: Stacy Rust 843-449-1010 srust@curcmb.com | |
Principal Investigator: Dr. Neal Shore, MD | |
United States, Tennessee | |
Site 02007 - Urology Associates, P. C | Recruiting |
Nashville, Tennessee, United States, 37209 | |
Contact: Aryssa Hudson 615-250-9282 aehudson@ua-pc.com | |
Principal Investigator: Dr. Gautam Jayram | |
United States, Texas | |
Site 02010 - Urology San Antonio P. A | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Kethsaly Salinas 210-617-4116 kethsaly.Salinas@urologysa.com | |
Principal Investigator: Dr. Daniel Saltzstein, MD | |
United States, Virginia | |
Site 02009 - Virginia Urology | Recruiting |
Richmond, Virginia, United States, 23235 | |
Contact: Christine Rose 804-288-2785 clrose@uro.com | |
Principal Investigator: Dr. Eugene Kramolowsky, MD | |
United States, Wisconsin | |
Site 02011 - University of Wisconsin Health | Recruiting |
Madison, Wisconsin, United States, 53705 | |
Contact: Sarah Sund 608-265-0027 Sund@ortho.wisc.edu | |
Principal Investigator: Dr. Kyle Richards, MD | |
Canada, British Columbia | |
Site 01005 - The Vancouver Prostate Centre - Diamond Health Care Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Contact: Genevive Moreau 604-875-5003 gbaloloy@prostatecentre.com | |
Principal Investigator: Peter Black, MD | |
Canada, Nova Scotia | |
Site 01004 - Nova Scotia Health Authority - Centre for Urology Research | Recruiting |
Halifax, Nova Scotia, Canada | |
Contact: Natasha Duggan, B.A. | |
Principal Investigator: Ricardo Rendon, M.D. | |
Sub-Investigator: Ross Mason, M.D. | |
Canada, Ontario | |
Site 01002- London Health Sciences Centre | Recruiting |
London, Ontario, Canada | |
Contact: Wendy Shoff | |
Principal Investigator: Joseph Chin, MD | |
Site 01001 - University Health Network | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Contact: Michael Nesbitt | |
Principal Investigator: Girish Kulkarni, MD | |
Canada, Quebec | |
Site 01003 - McGill University Health Centre | Recruiting |
Montréal, Quebec, Canada | |
Contact: Raphael Freitas | |
Principal Investigator: Wassim Kassouf, MD |
Principal Investigator: | Girish Kulkarni, MD, FRCSC | University Health Network, Toronto |
Responsible Party: | Theralase Inc. |
ClinicalTrials.gov Identifier: | NCT03945162 |
Other Study ID Numbers: |
TLD-1433 Bladder Cancer PDT |
First Posted: | May 10, 2019 Key Record Dates |
Last Update Posted: | May 12, 2022 |
Last Verified: | May 2022 |
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 Refractory to BCG |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |