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

Urothelial Carcinoma Clinical Trial

Official title: SURE-01_An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Sacituzumab Govitecan, Before Radical Cystectomy, for Patients With Muscleinvasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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).

The general framework of the study will be as follows:

A transurethral resection of the bladder tumor (TURBT) for biopsy, histological characterization, and local staging will be executed first, according to the guidelines. With the aim to improve the sensitivity of computed tomography (CT) scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, CT scan, 18F-fluorodeoxyglucose positron emission tomography (18FDG-PET)/CT scan, and multiparametric bladder magnetic resonance imaging (mpMRI) will be done during screening and before cystectomy to stage and evaluate response.

• Eligible patients will receive neoadjuvant treatment: 10 mg/kg sacituzumab govitecan IV, on days 1, 8, of each 21 day cycle.

• A total of 4 cycles is planned before surgery. Surgery will be planned at the time of study inclusion to be done within 4 weeks of the last dose of study drug. After surgery patients will be managed according to local guidelines which mirror the current EAU guidelines. ;

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

• NCT number: NCT05226117
• Study type: Interventional
• Source: IRCCS San Raffaele
• Contact: Andrea Necchi, MD
• Phone: 0226435789
• Email: necchi.andrea@hsr.it
• Status: Recruiting
• Phase: Phase 2
• Start date: November 29, 2021
• Completion date: June 2023