ABLE-22

Nature et Objective
This randomized, multicenter, open‑label Phase 3 trial will enroll adults with high‑grade BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC), including CIS with or without high‑grade Ta/T1 disease, who have received adequate BCG therapy and remain appropriate candidates for bladder‑sparing intravesical treatment. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).