At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 157 enrolled
Drug / intervention
ADSTILADRINbiological
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.
A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High-Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
In Brief
A Phase 3 clinical trial evaluating ADSTILADRIN for Superficial Bladder Cancer. Completed, enrolled 157 participants across 34 sites.
Detailed Summary
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuperficial Bladder Cancer
CountriesUnited States
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartSep 2016
Primary CompletionMay 2019
Study CompletionMay 2023
TodayJul 2026
First PostedMay 16, 2016
Enrollment StartSep 19, 2016
Primary CompletionMay 24, 2019
Study CompletionMay 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.1 years ago
Interventions
ADSTILADRINbiological