Actively Recruiting
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
Led by Verity Pharmaceuticals Inc. · Updated on 2026-03-20
540
Participants Needed
6
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 completely resected stage Ta or T1 urothelial carcinoma, with or without carcinoma in situ (CIS), within 45 days
- Imaging confirming no metastatic disease for T1 stage patients within 90 days
- Repeat TURBT performed as required within 60 days of initial TURBT and 45 days of registration
- Intermediate or high recurrence risk with ≥50% 2-year recurrence probability
- ECOG performance status of 0 to 2
- Adequate organ and marrow function including leukocytes ≥3000/mcL, neutrophils ≥1500/mcL, platelets ≥100,000/mcL, total bilirubin ≤1.5× institutional ULN, AST/ALT ≤3× ULN, and creatinine ≤ institutional ULN or GFR ≥50 mL/min/1.73 m2
- For women of childbearing potential: negative pregnancy test and willingness to use contraception for 120 days after last dose
- Women of non-childbearing potential defined by surgical sterilization or menopause with FSH confirmation
- Male patients with female partners of childbearing potential must agree to abstain or use effective contraception and avoid sperm donation during and for 120 days after treatment
You will not qualify if you...
- Urothelial carcinoma involving upper urinary tract or prostatic urethra within 12 months
- Carcinoma in situ (CIS) only disease
- Pure squamous cell carcinoma or adenocarcinoma
- Presence of micropapillary components
- Prior non-bladder malignancies except certain treated cancers or localized prostate cancer under surveillance
- Prior intravesical or intradermal BCG within 5 years except childhood tuberculosis vaccination
- Chronic steroid use >10 mg prednisone at randomization
- Concurrent or planned cancer therapies during study
- Prior chemoradiation (trimodal therapy) for bladder cancer
- Current treatment or planned treatment with systemic or intravesical chemotherapy during study
- Use of investigational agents
- Impaired immune response from any cause
- Known HIV infection with detectable viral load or current diagnosis of AIDS
- Presence of urinary tract infection
- Urinary bladder trauma or unresolved gross hematuria
- Allergic reactions to BCG or similar compounds
- Uncontrolled illnesses
- Psychiatric or social conditions limiting compliance
- Pregnancy or breastfeeding
AI-Screening
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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
CONTACT
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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