TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. (2025)

[BACKGROUND] Effective treatments are needed for patients with muscle-invasive bladder cancer scheduled for radical cystectomy who are ineligible for or decline to receive neoadjuvant cisplatin-based chemotherapy. We aimed to evaluate neoadjuvant TAR-200 plus cetrelimab (anti-PD-1) versus cetrelimab monotherapy in this setting.

[METHODS] SunRISe-4 is a randomised, open-label, phase 2 trial being conducted at 109 investigative centres in ten countries worldwide. Eligible patients were aged 18 years or older, were newly diagnosed with histologically confirmed muscle-invasive bladder cancer (stage cT2-cT4 N0M0), had an Eastern Cooperative Oncology Group performance status of 0-1, were scheduled to undergo radical cystectomy, and were deemed ineligible for or declined platinum-based neoadjuva