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Tests treatment safety and results for Bladder Cancer
Official title Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
ClinicalTrials.gov ID: NCT05037279
What this study is testing
What is Bacillus Calmette-Guerin: Strain Russian BCG-I?
Bacillus Calmette-Guerin: Strain Russian BCG-I is an investigational medicine, given as an once-weekly, being studied as a potential treatment for bladder cancer.
Also referred to as Verity-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
- The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Male or Female
- 18 years and older
- Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification and...
- Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS)...
- Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within (before or after) 90 days...
You likely can't join if
- Presence of urothelial carcinoma involving the upper urinary tract or prostatic urethra documented by radiological imaging or biopsy, performed...
- CIS only disease.
- Pure squamous cell carcinoma or adenocarcinoma.
- Presence of micropapillary components.
- Other prior non-bladder malignancy, except for the following:
- patients presenting with NMIBC recurrent tumor(s)
See the full eligibility criteria
- Male or Female
- 18 years and older
- Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification and Grade 2 or 3 in the 1973 classification, diagnosed within 45 days of...
- Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diagnosed within 45 days of registration.
- Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within (before or after) 90 days of registration, to confirm stage T1N0M0 disease.
- For patients with stage T1 disease, a repeat TURBT must be performed as per standard of care/CUA guidelines. A repeat TURBT may also be required for patients with Ta disease. Repeat TURBT must be performed within 60...
- Patients may have intermediate or high recurrence risk disease, as indicated by the probability of 2-year recurrence of ≥ 50% based on the EORTC Bladder Cancer risk calculator.
- ECOG performance status of 0-2
- Adequate organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use of BCG at lower kidney function values, no lower than 30 mL/min/1.73 m2
- For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during 120 days after...
- Note: A woman of non-childbearing potential is defined as follows:
- Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);
- Has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for...
- Male patients with female partner of childbearing potential must agree to be abstinent or practice an effective method of contraception. Male patients must agree to refrain from donating sperm during the treatment...
- Presence of urothelial carcinoma involving the upper urinary tract or prostatic urethra documented by radiological imaging or biopsy, performed within 12 months of the start of treatment. Should the imaging or biopsy be...
- CIS only disease.
- Pure squamous cell carcinoma or adenocarcinoma.
- Presence of micropapillary components.
- Other prior non-bladder malignancy, except for the following:
- patients presenting with NMIBC recurrent tumor(s)
- adequately treated basal cell or squamous cell skin cancer.
- in situ cervical cancer.
- adequately treated stage I or II cancer currently in complete remission, or any other cancer from which the patient has been disease free for five years.
- patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
- Prior intravesical BCG or intradermal BCG, within 5 years of screening, with the exception of tuberculosis vaccination in childhood.
- Chronic administration of steroids (\>10 mg prednisone) at the time of randomization.
- Current or planned concomitant biologic therapy, radiation therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.
- Prior chemoradiation treatment (trimodal therapy or "TMT") for bladder cancer.
- Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
- Receiving any other investigational agents.
- The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.
- Known positive HIV serology with detectable viral load.
- Current diagnosis of AIDS
- Presence of a urinary tract infection; treatment should be withheld until urine culture is negative and antibiotic therapy is stopped.
- Trauma to the urinary bladder. In case of gross hematuria, therapy should be stopped or postponed until the hematuria has been successfully treated or has resolved.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.
- Uncontrolled intercurrent illness.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnancy: pregnant women are excluded from this study because VERITY-BCG is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in...
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Kingston, 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 Vancouver, British Columbia, Canada; Kingston, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. 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.