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.
Protocol Amendment History
2 changes
criticalTrial status changed: Not Yet Recruiting → Withdrawn2026-05-20