Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer

Summary

SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).

Timeline

Start

2022-03-23

Primary completion

2025-09-24

Completion

2025-09-24

Publications

• Necchi A, de Jong JJ, Maiorano BA, Proudfoot JA, Basile G, Cigliola A, Mercinelli C, Tateo V, Piacentini M, Crupi E, Pastorino GL, Latini G, Tomasi E, Davicioni E, Moschini M, Brembilla G, Colecchia M, de Cobelli F, Ross JS, Madison R, Tambaoan CFB, Briganti A, Montorsi F. Neoadjuvant Sacituzumab Govitecan in Patients With Muscle-Invasive Bladder Cancer: Primary Results of the SURE-01 Trial. J Clin Oncol. 2026 May 31:JCO2600142. doi: 10.1200/JCO-26-00142. Online ahead of print.

Drugs

Indications