NCT05037279View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

April 24, 2024

Primary Completion Date

February 28, 2029

Study Completion Date

February 28, 2029

Conditions
Bladder CancerBladder Cancer RecurrentNeoplasm RecurrenceUrothelial Carcinoma BladderUrothelial Carcinoma RecurrentNon-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."

Trial Locations (6)

Unknown

RECRUITING

Site 05, Vancouver

RECRUITING

Site 04, Kingston

RECRUITING

Site 01, Toronto

NOT_YET_RECRUITING

Site 02, Toronto

RECRUITING

Site 08, Toronto

NOT_YET_RECRUITING

Site 10, Montreal

All Listed Sponsors
lead

Verity Pharmaceuticals Inc.

INDUSTRY