Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (NCT05037279)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (26 items).
Location: Site 05 — Vancouver, British Columbia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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 performed outside the window it will be up to the physicians' discretion to re-scan/biopsy. This is considered T4 disease.
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Site 05 — Vancouver, British Columbia
- Site 04 — Kingston, Ontario
- Site 01 — Toronto, Ontario
- Site 02 — Toronto, Ontario
- Site 08 — Toronto, Ontario
- Site 10 — Montreal, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.