KEYNOTE-905 / EV-303 — Perioperative pembrolizumab, with or without enfortumab vedotin, in cisplatin-ineligible muscle-invasive bladder cancer

Phase 3 · Bladder Cancer, Urothelial Carcinoma

Population

Muscle-invasive bladder cancer in patients who are cisplatin-ineligible or decline cisplatin, undergoing radical cystectomy.

Primary Endpoint

Pathologic complete response and event-free survival

Rationale

Cisplatin-based neoadjuvant chemotherapy improves survival before cystectomy, but many patients cannot receive cisplatin and currently have no proven perioperative option. This trial tests perioperative pembrolizumab, alone or combined with enfortumab vedotin, to fill that gap.

What It Could Change

Could define the first standard perioperative therapy for cisplatin-ineligible muscle-invasive bladder cancer.