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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05037279
Study type Interventional
Source Verity Pharmaceuticals Inc.
Contact Jalees Farhan
Phone 1-800-977-9778
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date January 1, 2022
Completion date August 30, 2026

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