Actively Recruiting
A Multicenter, Randomized, Double-blind, Controlled Phase III Study Comparing VERITY-BCG to OncoTICE in Intermediate and High-risk Non-muscle Invasive Bladder Cancer Patients Without Prior BCG Treatment
Led by Verity Pharmaceuticals Inc. · Updated on 2026-03-20
540
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) who have never been treated with intradermal or intravesical BCG before, except for childhood tuberculosis vaccination. The study aims to compare Verity-BCG to the current standard BCG treatment, OncoTICE, to see if Verity-BCG is at least as effective in preventing cancer recurrence over 24 months. This randomized, double-blind trial focuses on patients at high risk of recurrence, defined as greater than 50%, and evaluates the recurrence-free survival rates as the primary outcome.
CONDITIONS
Brief Title
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female
- 18 years and older
- Diagnosed with low or high-grade non-muscle-invasive bladder cancer (NMIBC) within 45 days
- Pathologically confirmed and fully removed stage Ta or T1 urothelial cell carcinoma, with or without carcinoma in situ, within 45 days
- Imaging confirming no metastatic disease for T1 patients within 90 days
- Repeat TURBT as required within 60 days of initial surgery and 45 days of registration with pathological confirmation
- Intermediate or high recurrence risk with ≥50% chance of 2-year recurrence
- ECOG performance status of 0 to 2
- Adequate organ and marrow function including specific blood counts and kidney function
- Negative pregnancy test and use of contraception for women of childbearing potential
- Male patients agree to abstain or use contraception and refrain from sperm donation during and 120 days after treatment
- Women of non-childbearing potential defined by surgical sterilization or confirmed cessation of menses
You will not qualify if you...
- Urothelial carcinoma involving upper urinary tract or prostatic urethra within 12 months
- Carcinoma in situ only disease
- Pure squamous cell carcinoma or adenocarcinoma
- Presence of micropapillary components
- Prior non-bladder malignancies except certain skin cancers, in situ cervical cancer, treated early-stage cancers, or localized prostate cancer under surveillance
- Prior intravesical or intradermal BCG within 5 years except childhood tuberculosis vaccination
- Chronic steroid use over 10 mg prednisone at randomization
- Concurrent or planned cancer therapies during the study
- Prior chemoradiation for bladder cancer
- Treatment or planned treatment with other chemotherapeutic agents during the study
- Use of other investigational agents
- Impaired immune response from any cause
- Known HIV infection with detectable viral load or current AIDS diagnosis
- Active urinary tract infection
- Recent bladder trauma or gross hematuria until resolved
- Allergic reactions to BCG or similar compounds
- Uncontrolled illness
- Psychiatric or social issues limiting compliance
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive weekly bladder instillations of the study drug for 6 weeks, followed by maintenance treatments for 3 weeks at scheduled months based on risk level.
Weekly visits for 6 weeks, then 3-week maintenance treatments at 3, 6, 12 months for intermediate risk; additional maintenance at 18, 24, 30, and 36 months for high risk
Trial Site Locations
Total: 6 locations
1
Site 05
Vancouver, British Columbia, Canada
Actively Recruiting
2
Site 04
Kingston, Ontario, Canada
Actively Recruiting
3
Site 01
Toronto, Ontario, Canada
Actively Recruiting
4
Site 02
Toronto, Ontario, Canada
Not Yet Recruiting
5
Site 08
Toronto, Ontario, Canada
Actively Recruiting
6
Site 10
Montreal, Quebec, Canada
Not Yet Recruiting
Research Team
T
Taniya Mann, PhD, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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