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

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.

Trial Details

NCT ID
NCT05037279
Phase
PHASE3
Sponsor
Verity Pharmaceuticals Inc.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Bacillus Calmette-Guerin: Strain Russian BCG-I
  • Bacillus Calmette-Guerin: Strain TICE
Locations (sample)
  • Vancouver, British Columbia, Canada|49.24966,-123.11934
  • Kingston, Ontario, Canada|44.22976,-76.48098
  • Toronto, Ontario, Canada|43.70643,-79.39864
  • Toronto, Ontario, Canada|43.70643,-79.39864
  • Toronto, Ontario, Canada|43.70643,-79.39864

Key Eligibility Criteria

  • Male or Female
  • 18 years and older
  • Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification and …
  • Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diag…

For full eligibility, visit ClinicalTrials.gov.

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