RecruitingPhase 3

Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)

Canada540 participantsStarted 2024-04-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within (before or after) 90 days of registration, to confirm stage T1N0M0 disease.
✓. For patients with stage T1 disease, a repeat TURBT must be performed as per standard of care/CUA guidelines. A repeat TURBT may also be required for patients with Ta disease. Repeat TURBT must be performed within 60 days of the initial TURBT and within 45 days of registration. Pathological confirmation is required after the repeat TURBT.

What they're measuring

Recurrence Free Survival (RFS) at 24 months

Timeframe: 24 months

Trial details

NCT IDNCT05037279

SponsorVerity Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

Taniya Mann, PhD, MBA

800-977-9778 medinfo@veritypharma.com

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