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New treatment option for Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant...
Official title Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
ClinicalTrials.gov ID: NCT03945162
What this study is testing
What is Ruvidar® (TLD-1433) bladder infusion and PDT?
Ruvidar® (TLD-1433) bladder infusion and PDT is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for non-muscle invasive bladder cancer ("nmibc") unresponsive/intolerant to bcg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Active gross hematuria.
- Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous...
- Have a history or current evidence of any condition, therapy, surgery or laboratory abnormality that, in the opinion of the PI, might confound the...
- Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications).
See the full eligibility 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...
- 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 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Greenwood, Indiana, United States
- Syracuse, New York, United States
- Gahanna, Ohio, United States
- Bala-Cynwyd, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Richmond, Virginia, United States
- Madison, Wisconsin, United States
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Greenwood, Indiana, United States; Syracuse, New York, United States; Gahanna, Ohio, United States; Bala-Cynwyd, Pennsylvania, United States; Myrtle Beach, South Carolina, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.