Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.
Verity Pharmaceuticals Inc.
540 participants
Apr 24, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
* Induction: 80 mg weekly for 6 weeks. * Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months. * Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.
* Induction: 50 mg weekly for 6 weeks. * Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months. * Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.
Locations(6)
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NCT05037279