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

NCT05037279 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Verity Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Girish S Kulkarni, MD · Princess Margaret Cancer Centre, 700 University Ave, 6-824 Toronto, ON, M5G 1X6, Canada

  • Alexandre R Zlotta, MD, PhD, FRCSC · Mount Sinai Hospital, 600 University Avenue, Toronto, ON, M5G 1X5

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037279 on ClinicalTrials.gov