At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 133 enrolled
Drug / intervention
Viciniumbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label, Multicenter, Ph 3 [Phase 3] Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG
In Brief
A Phase 3 clinical trial evaluating Vicinium for Bladder Cancer. Completed, enrolled 133 participants across 70 sites in 2 countries.
Detailed Summary
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartAug 2015
Primary CompletionMay 2020
Study CompletionMay 2022
TodayJul 2026
First PostedMay 20, 2015
Enrollment StartAug 1, 2015
Primary CompletionMay 1, 2020
Study CompletionMay 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.1 years ago
Interventions
Viciniumbiological
Intravesical administration