Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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).