RecruitingPhase 3NCT05037279

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.


Sponsor

Verity Pharmaceuticals Inc.

Enrollment

540 participants

Start Date

Apr 24, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety and effectiveness of Verity-BCG — a type of immunotherapy delivered directly into the bladder — in patients with non-muscle-invasive bladder cancer (cancer that hasn't grown into the bladder's muscle wall) who have never had BCG treatment before. **You may be eligible if...** - You are 18 or older with bladder cancer (stage Ta or T1) that has been completely removed by surgery - Your cancer has an intermediate or high risk of returning - You have never had BCG treatment in your bladder - Your kidney function, blood counts, and liver function are adequate - You are not pregnant and agree to use contraception **You may NOT be eligible if...** - Your cancer has spread to the upper urinary tract or prostate - You have only carcinoma-in-situ (CIS), squamous cell or glandular cancer - You have had BCG treatment before (except a childhood tuberculosis vaccine) - You have HIV or an impaired immune system - You have an active urinary tract infection - You are currently taking chronic steroids or undergoing other cancer therapies - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBacillus Calmette-Guerin: Strain Russian BCG-I

* 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.

DRUGBacillus Calmette-Guerin: Strain TICE

* 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)

Site 05

Vancouver, British Columbia, Canada

Site 04

Kingston, Ontario, Canada

Site 01

Toronto, Ontario, Canada

Site 02

Toronto, Ontario, Canada

Site 08

Toronto, Ontario, Canada

Site 10

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT05037279


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