Study #2016-0342
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)
MD Anderson Study Status
Not Accepting
Treatment Agent
INSTILADRIN
Description
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that INSTILADRIN (nadofaragene firadenovec) 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 INSTILADRIN 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.
Information and next steps
Disease:
Superficial Bladder Cancer
Study phase:
III
Physician name:
Ashish Kamat
Department:
Urology
For general questions about clinical trials:
1-877-632-6789
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