NCT05037279

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Verity Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, active control, double-blind clinical trial aimed at demonstrating non - inferiority of VERITY-BCG to OncoTICE, the current standard of care, with respect to two-year Recurrence Free Survival (RFS) rates in NMIBC BCG - naïve patients that are at high risk for recurrence (defined as \>50%). • Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

Conditions

• Bladder Cancer
• Bladder Cancer Recurrent
• Neoplasm Recurrence
• Urothelial Carcinoma Bladder
• Urothelial Carcinoma Recurrent
• Non-Invasive Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Bacillus 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.
DRUG	Bacillus 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.

Timeline

• Start date: 2024-04-24
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2021-09-08
• Last updated: 2026-03-20

Locations

6 sites across 1 country: Canada