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.
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 Grade 2 or 3 in the 1973 classification, diagnosed within 45 days of registration.
Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diagnosed within 45 days of registration.
Presence of urothelial carcinoma involving the upper urinary tract or prostatic urethra documented by radiological imaging or biopsy, performed within 12 months of the start of treatment. Should the imaging or biopsy be performed outside the window it will be up to the physicians' discretion to re-scan/biopsy. This is considered T4 disease.
CIS only disease.
Pure squamous cell carcinoma or adenocarcinoma.
Presence of micropapillary components.
Parallel
Bacillus Calmette-Guerin: Strain Russian BCG-I
Drug* 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.
Bacillus Calmette-Guerin: Strain TICE
Drug* 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.
Recurrence Free Survival (RFS) at 24 months
Cumulative Recurrence Free Survival (RFS) at 24 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function. Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.
Recurrence Free Survival (RFS)
Cumulative Recurrence Free Survival (RFS) at 36 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.
Progression Free Survival (PFS)
Progression Free Survival (PFS) at 24 months as estimated using the Kaplan - Meier estimator of the survival function.
Progression Free Survival (PFS)
Progression Free Survival (PFS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.
Overall Survival (OS)
Overall Survival (OS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.
Safety: Incidence of treatment-emergent AEs and SAEs
Incidence of treatment-emergent AEs and SAEs defined according to the CTCAE v5.0;
Safety: Number of discontinued subjects
Number of subjects discontinuing study drug due to AEs
Safety: concomitant medications
Usage of concomitant medications over time.
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