ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer

Summary

This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1 papillary disease. The purpose of this study is to evaluate the contribution of effect of neoadjuvant ANKTIVA plus BCG experimental therapy in papillary NMIBC.

Timeline

Start

2026-05-15

Primary completion

2032-05

Completion

2032-05

Drugs

Indications