Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC

Summary

This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.

Timeline

Start

2019-03-20

Primary completion

2019-11-18

Completion

2019-12-18

Outcome

Outcome not reported

Stopped: “Lack of efficacy”

Drugs

Indications