New hope for bladder cancer patients who failed standard treatment
NCT ID NCT03945162
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called Ruvidar, given directly into the bladder, for people with a type of bladder cancer that did not respond to or could not tolerate standard BCG therapy. About 90 adults will receive up to three treatment sessions. The main goal is to see if the drug can make the cancer disappear completely.
Why investors are watching
Theralase Technologies is running a phase II trial of its drug ruvidar for a type of bladder cancer that has stopped responding to standard BCG therapy. For a micro-cap company, this single trial is a major part of its value, so the readout will likely drive investor attention. The trial tests whether ruvidar can control the disease in 90 patients who have few other options.
If it works: If the trial shows ruvidar controls the cancer, Theralase could have a product for a patient group with limited alternatives. That result could support further development and potential partnerships.
If it fails: Phase II trials often fail to meet their goals, and this one is small and single-arm, so positive results may not hold up in larger studies. A failure or delay could hurt the company's prospects, as it has few other assets to fall back on.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2019
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Site 01-001 - University Health Network - Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2C4, Canada
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Site 01-002- London Health Sciences Centre - Victoria Hospital
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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Site 01-003 - McGill University Health Centre - Glen-Cedars Cancer Centre
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Site 01-004 - Nova Scotia Health Authority - Centre for Applied Urology Research
RECRUITINGHalifax, Nova Scotia, B3H 2Y9, Canada
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Site 01-005 - The Vancouver Prostate Centre - Diamond Health Care Centre - Vancouver General Hospital
RECRUITINGVancouver, British Columbia, V5Z 1M9, Canada
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Site 01-014 - St. Joseph's Healthcare
RECRUITINGHamilton, Ontario, L8N 4A6, Canada
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Site 02-006 - Carolina Urologic Research Center
RECRUITINGMyrtle Beach, South Carolina, 29572, United States
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Site 02-007 - Urology Associates, P. C
RECRUITINGNashville, Tennessee, 37209, United States
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Site 02-008 - MidLantic Urology
TERMINATEDBala-Cynwyd, Pennsylvania, 19004, United States
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Site 02-009 - Virginia Urology
TERMINATEDRichmond, Virginia, 23235, United States
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Site 02-010 - Urology San Antonio P. A
TERMINATEDSan Antonio, Texas, 78229, United States
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Site 02-011 - University of Wisconsin Health University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
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Site 02-012 - University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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Site 02-015 - Associated Medical Professionals of New York
RECRUITINGSyracuse, New York, 13210, United States
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Site 02-016 - Urology of Indiana
RECRUITINGGreenwood, Indiana, 46143, United States
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Site 02-017 - Central Ohio Urology Group
RECRUITINGGahanna, Ohio, 43230, United States
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