Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCGPhase 2NCT03945162
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
A Phase 2 study testing Ruvidar® (TLD-1433) bladder infusion and PDT in people with Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG, run by Theralase® Technologies Inc. at 16 sites in 2 countries.
Trial summary
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin ("BCG")-Unresponsive or who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG
- What is being tested?
- Ruvidar® (TLD-1433) bladder infusion and PDT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 30 Aug 2019to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Procedure date to confirm: histology, grade and stage.
- 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.
Show all 12Show fewer
- 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 Procedure.
- 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.
Who cannot join
- Past or current muscle invasive (i.e.: T2, T3, T4) or metastatic urothelial carcinoma.
- 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.
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- 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 Procedure.
- 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 last Study Procedure.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
United States10 sites, 7 recruiting
- Terminated
Site 02-008 - MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
- Recruiting
Site 02-012 - University of Chicago
Chicago, Illinois, 60637
Megan Mendez, 773-702-2081, Megan.Mendez@medicine.bsd.uchicago.edu
Piyush Agarwal, MD
- Recruiting
Site 02-017 - Central Ohio Urology Group
Gahanna, Ohio, 43230
Benjamin Carey, 614-393-2684 ext. 22801, bcarey@centralohiourology.com
Dr. Benjamin Martin
- Recruiting
Site 02-016 - Urology of Indiana
Greenwood, Indiana, 46143
Brittiny Currin, 631-838-6670, bcurrin@urologyin.com
Dr. Eugene Cone
- Recruiting
Site 02-011 - University of Wisconsin Health University Hospital
Madison, Wisconsin, 53792
Abigail Wiedmer, 608-265-9172, wiedmer@urology.wisc.edu
Dr. Kyle Richards, MD
- Recruiting
Site 02-006 - Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Jennifer Sutton, 843-449-1010 ext. 316, jsutton@curcmb.com
Jessica Richardson, 843-449-1010 ext. 261, jrichardson@curcmb.com
- Recruiting
Site 02-007 - Urology Associates, P. C
Nashville, Tennessee, 37209
Tiffany Paine, 615-250-9282, tmpaine@ua-pc.com
Dr. Gautam Jayram
- Terminated
Site 02-009 - Virginia Urology
Richmond, Virginia, 23235
- Terminated
Site 02-010 - Urology San Antonio P. A
San Antonio, Texas, 78229
- Recruiting
Site 02-015 - Associated Medical Professionals of New York
Syracuse, New York, 13210
Nora Hoodmaker, 315-558-6619, NHoodmaker@ampofny.com
Dr. Ilija Aleksic
Canada6 sites, 6 recruiting
- Recruiting
Site 01-004 - Nova Scotia Health Authority - Centre for Applied Urology Research
Halifax, Nova Scotia, B3H 2Y9
Natasha Duggan, 902-473-7969, natasha.duggan@nshealth.ca
Ricardo Rendon, M.D.
- Recruiting
Site 01-014 - St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
M. Teresa Balart, MD, (905) 522-1155 ext. 37074, mbalart@stjoes.ca
Avinash Chekuri, savinash@stjosham.on.ca
- Recruiting
Site 01-002- London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Wendy Shoff, 519-685-8500 ext. 57350, wendy.shoff@lhsc.on.ca
Jonathan Izawa, MD
- Recruiting
Site 01-003 - McGill University Health Centre - Glen-Cedars Cancer Centre
Montreal, Quebec, H4A 3J1
Karla Jauregui Sanchez, 514-934-1934 ext. 34905, karla.jaureguisanchez@muhc.mcgill.ca
Wassim Kassouf, MD
- Recruiting
Site 01-001 - University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Sarah Cheung, 437-335-2949, sarah.cheung@uhn.ca
Girish Kulkarni, MD
- Recruiting
Site 01-005 - The Vancouver Prostate Centre - Diamond Health Care Centre - Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Genevive Moreau, 604-875-4111 ext. 67898, gbaloloy@prostatecentre.com
Peter Black, MD
About this study
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")
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("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 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
Read the detailed description
- Overall Study Design and Plan: Description 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 BCG-Unresponsive or are intolerant to BCG therapy that meet the inclusion and exclusion criteria will be enrolled and treated. The Study will consist of 90 patients who will receive one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
- Screening Period Patients will be qualified for Study II entry by review of inclusion and exclusion criteria during the Screening Period, which will last up to 60 days.
- Follow-Up Phase All patients enrolled and treated by the treatment procedure will be followed until the End of Study defined as completion of all required assessments after 15 months of follow-up post primary study treatment or due to early discontinuation or withdrawal of informed consent. During the Follow-Up Phase, information on efficacy and safety will be collected. Assessments will be conducted at Day 0, 7, 90, 180, 270, 360 and 450 days. Survival surveillance for all patients who achieve a CR or Indeterminate Response ("IR") (negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies) at four hundred and fifty (450) days and remain in Study II will be monitored for up to one thousand and eighty (1080) days post primary Study II Treatment, recording: efficacy, safety and incidence of radical cystectomy every ninety (90) days for the first seven hundred and twenty (720) days, then every one hundred and eighty (180) days, until one thousand and eighty (1080) days.
- Study Drug and PDT Administration
Ruvidar® (TLD-1433) for intravesical administration is supplied as a lyophilisate for suspension in Sterile Water For Injection ("SWFI") into the bladder and is packaged in the dark in amber USP Type III glass vials, which are stored at 3 to 8 degree Celsius. Up to 24 hours before administration, it is reconstituted with SWFI to obtain the final clinical dilution.
Ruvidar® (TLD-1433) will be supplied to each Study II site by Theralase®. Instillations cannot be done immediately following biopsy taken by Trans-Urethral Resection of Bladder Tumour ("TURBT"). Investigators must wait a minimum of 7 days before dosing patients after a TURBT/biopsy, and/or until any bladder wall integrity issues have resolved. Dose/volume reductions are not allowed during Study II.
Upon determination of the bladder volume (during the screening period) through a self-recorded voiding diary, Ruvidar® (TLD-1433) will be diluted with SWFI to the proper concentration. On day 0 (Primary Study Procedure day), patients will be asked to restrict fluid intake 12 hours before Study Drug instillation. Study Drug must be instilled into the patient's empty bladder. Before instillation, a regular transurethral catheter should be inserted and the bladder drained. A single instillation of Ruvidar® (TLD-1433) will be infused intravesically for approximately 60 minutes, followed by 1 wash with SWFI. The bladder will be distended using a second instillation of SWFI to prevent folds that may prevent uniform light illumination. The Computer Operator worksheet must be completed during the Study Procedure and data must be promptly transferred to the corresponding electronic Case Report Form ("eCRF") page.
The optical fiber with spherical diffuser will be positioned through the cystoscope in the geometric center of the bladder with the aid of TLC-3200 and will be locked into place using an endoscope holder for continuous irradiation for the total exposure time. The optical power and treatment time will be determined to provide the correct dose of laser light to the bladder surface area. Green laser light (wavelength = 532 nm, energy = 90 J/cm2) will be irradiated from the emitter optical fiber via the spherical diffuser.
4.1 Dosing Schedule
One Study Procedure is planned, with up to two additional re-induction Study Procedures based on patient response. Each Study Procedure is a single whole bladder intravesical Ruvidar® (TLD-1433) instillation followed by PDT with the TLC-3200 System.
4.2 PDT Disruption
Patients with persistent or recurrent NMIBC CIS alone (or with recurrent Ta/T1 (noninvasive papillary disease/tumour invades the subepithelial connective tissue)) disease within 12 months of completion of BCG therapy (BCG-Unresponsive) or who are intolerant to BCG therapy will be treated with this Protocol. If one or more papillary tumours are seen at the time of Study Treatment (maximum 12 weeks after TURBT), the patient will be resected via TURBT and will be treated with this Protocol.
- Being tested
- Ruvidar® (TLD-1433) bladder infusion and PDT
- Keywords
- Photodynamic Therapy, Non-muscle invasive bladder cancer ("NMIBC"), Urothelial carcinoma, Ta bladder cancer, T1 bladder cancer, Unresponsive/Intolerant to BCG
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruvidar® (TLD-1433) bladder infusion and PDTCombination product
Ruvidar® (TLD-1433) is infused into the bladder and treatment of bladder wall with PDT light activation using the TLC-3200 system.
| Study group | Role | What they receive |
|---|---|---|
| 0.70 mg/cm^2 Ruvidar® (TLD-1433) Bladder instillation and Photodynamic Therapy | Experimental | Each Study Procedure is a single instillation of Ruvidar® (TLD-1433) (at the therapeutic dose of 0.70 mg/cm^2) will be infused intravesically into the bladder for approximately 60 minutes, followed by PDT treatment using the TLC-3200 system, which is performed after Ruvidar® (TLD-1433) has been rinsed from the bladder. One Study Procedure will be performed, with up to 2 additional re-induction Study Procedures based on patient response. Receives: Combination Product: Ruvidar® (TLD-1433) bladder infusion and PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy, evaluated by Complete Response ("CR").
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.
Measured: Throughout Study II and up to the completion of the follow-up phase (15 month)
Secondary outcomes (2)
Efficacy, evaluated by the duration of CR
Assessment of the Duration the CR is maintained after an initial CR is achieved.
Measured: Throughout Study II and up to the completion of the follow-up phase (15 month)
Three year patient assessments, for observation only.
Survival surveillance for all patients who achieve a CR or Indeterminate Response ("IR") (negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies) at four hundred and fifty (450) days and remain in Study II will be monitored for up to one thousand and eighty (1080) days post primary Study Procedure, recording: efficacy, safety and incidence of radical cystectomy every ninety (90) days for the first seven hundred and twenty (720) days, then every one hundred and eighty (180) days, until one thousand and eighty (1080) days.
Measured: Follow-up phase from 15 to 36 months for those who remain in Study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start30 Aug 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theralase® Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Girish Kulkarni, MD, FRCSC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945162
- Sponsor's protocol ID
- Ruvidar® (TLD-1433) NMIBC PDT
- Status last verified
- Nov 2025
- First submitted
- 8 May 2019
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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")
- ClinicalTrials.gov ID
- NCT03945162
- Acronym / sponsor ID
- Ruvidar® (TLD-1433) NMIBC PDT
- Keywords
- Photodynamic Therapy, Non-muscle invasive bladder cancer ("NMIBC"), Urothelial carcinoma, Ta bladder cancer, T1 bladder cancer, Unresponsive/Intolerant to BCG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Theralase® Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("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 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
Detailed description
- Overall Study Design and Plan: Description 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 BCG-Unresponsive or are intolerant to BCG therapy that meet the inclusion and exclusion criteria will be enrolled and treated. The Study will consist of 90 patients who will receive one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
- Screening Period Patients will be qualified for Study II entry by review of inclusion and exclusion criteria during the Screening Period, which will last up to 60 days.
- Follow-Up Phase All patients enrolled and treated by the treatment procedure will be followed until the End of Study defined as completion of all required assessments after 15 months of follow-up post primary study treatment or due to early discontinuation or withdrawal of informed consent. During the Follow-Up Phase, information on efficacy and safety will be collected. Assessments will be conducted at Day 0, 7, 90, 180, 270, 360 and 450 days. Survival surveillance for all patients who achieve a CR or Indeterminate Response ("IR") (negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies) at four hundred and fifty (450) days and remain in Study II will be monitored for up to one thousand and eighty (1080) days post primary Study II Treatment, recording: efficacy, safety and incidence of radical cystectomy every ninety (90) days for the first seven hundred and twenty (720) days, then every one hundred and eighty (180) days, until one thousand and eighty (1080) days.
- Study Drug and PDT Administration
Ruvidar® (TLD-1433) for intravesical administration is supplied as a lyophilisate for suspension in Sterile Water For Injection ("SWFI") into the bladder and is packaged in the dark in amber USP Type III glass vials, which are stored at 3 to 8 degree Celsius. Up to 24 hours before administration, it is reconstituted with SWFI to obtain the final clinical dilution.
Ruvidar® (TLD-1433) will be supplied to each Study II site by Theralase®. Instillations cannot be done immediately following biopsy taken by Trans-Urethral Resection of Bladder Tumour ("TURBT"). Investigators must wait a minimum of 7 days before dosing patients after a TURBT/biopsy, and/or until any bladder wall integrity issues have resolved. Dose/volume reductions are not allowed during Study II.
Upon determination of the bladder volume (during the screening period) through a self-recorded voiding diary, Ruvidar® (TLD-1433) will be diluted with SWFI to the proper concentration. On day 0 (Primary Study Procedure day), patients will be asked to restrict fluid intake 12 hours before Study Drug instillation. Study Drug must be instilled into the patient's empty bladder. Before instillation, a regular transurethral catheter should be inserted and the bladder drained. A single instillation of Ruvidar® (TLD-1433) will be infused intravesically for approximately 60 minutes, followed by 1 wash with SWFI. The bladder will be distended using a second instillation of SWFI to prevent folds that may prevent uniform light illumination. The Computer Operator worksheet must be completed during the Study Procedure and data must be promptly transferred to the corresponding electronic Case Report Form ("eCRF") page.
The optical fiber with spherical diffuser will be positioned through the cystoscope in the geometric center of the bladder with the aid of TLC-3200 and will be locked into place using an endoscope holder for continuous irradiation for the total exposure time. The optical power and treatment time will be determined to provide the correct dose of laser light to the bladder surface area. Green laser light (wavelength = 532 nm, energy = 90 J/cm2) will be irradiated from the emitter optical fiber via the spherical diffuser.
4.1 Dosing Schedule
One Study Procedure is planned, with up to two additional re-induction Study Procedures based on patient response. Each Study Procedure is a single whole bladder intravesical Ruvidar® (TLD-1433) instillation followed by PDT with the TLC-3200 System.
4.2 PDT Disruption
Patients with persistent or recurrent NMIBC CIS alone (or with recurrent Ta/T1 (noninvasive papillary disease/tumour invades the subepithelial connective tissue)) disease within 12 months of completion of BCG therapy (BCG-Unresponsive) or who are intolerant to BCG therapy will be treated with this Protocol. If one or more papillary tumours are seen at the time of Study Treatment (maximum 12 weeks after TURBT), the patient will be resected via TURBT and will be treated with this Protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.70 mg/cm^2 Ruvidar® (TLD-1433) Bladder instillation and Photodynamic Therapy | Experimental | Combination Product: Ruvidar® (TLD-1433) bladder infusion and PDTEach Study Procedure is a single instillation of Ruvidar® (TLD-1433) (at the therapeutic dose of 0.70 mg/cm^2) will be infused intravesically into the bladder for approximately 60 minutes, followed by PDT treatment using the TLC-3200 system, which is performed after Ruvidar® (TLD-1433) has been rinsed from the bladder. One Study Procedure will be performed, with up to 2 additional re-induction Study Procedures based on patient response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 Procedure date to confirm: histology, grade and stage.
- Intolerant to BCG or considered BCG-Unresponsive, which is at least one of the following:
- Are not candidates for cystectomy on medical grounds or refuse radical cystectomy.
Key exclusion criteria (12 listed)
- Past or current muscle invasive (i.e.: T2, T3, T4) or metastatic urothelial carcinoma.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruvidar® (TLD-1433) bladder infusion and PDTRuvidar® (TLD-1433) is infused into the bladder and treatment of bladder wall with PDT light activation using the TLC-3200 system. | Combination product | 0.70 mg/cm^2 Ruvidar® (TLD-1433) Bladder instillation and Photodynamic Therapy |
Primary outcome
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 suspected in the upper tract or prostatic urethra and random bladder biopsies are negative.
2 secondary outcomes
Efficacy, evaluated by the duration of CR
Time frame: Throughout Study II and up to the completion of the follow-up phase (15 month)
Three year patient assessments, for observation only.
Time frame: Follow-up phase from 15 to 36 months for those who remain in Study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Girish Kulkarni, MD, FRCSC principal investigator
University Health Network, Toronto
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruvidar® (TLD-1433) bladder infusion and PDT in people with Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG, run by Theralase® Technologies Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arkady Mandel, MD, PhD, DSc (416-699-5273 ext. 242, amandel@theralase.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy, evaluated by Complete Response ("CR"). (time frame: Throughout Study II and up to the completion of the follow-up phase (15 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.