Dickon Hayne, Katherine Ong, Nicole Swarbrick, Steve P McCombie, Andrew Moe, Cynthia Hawks, Pravin Viswambaram, Ciara Conduit, Elizabeth Liow, Lisa Spalding, Jayne Lim, Thomas Ferguson, Katie Meehan, Ian D Davis, Andrew D Redfern
OBJECTIVES: To assess the safety of sub-urothelial injection of durvalumab and examine the impact on tissue and circulating immune cell populations. PATIENTS AND METHODS: The patients were chemotherapy and immunotherapy naïve (bacille Calmette-Guérin allowed) with non-metastatic muscle-invasive bladder cancer or non-muscle-invasive bladder cancer planned for radical cystectomy (RC). The study was a Phase Ib 3 + 3 dose-escalation design with sub-urothelial injection of durvalumab at three pre-determined doses (25, 75, 150 mg) diluted in 25 mL normal saline, injected at 25 locations (25 × 1 mL injections), at least 2 weeks before RC...
March 12, 2024: BJU International