NCT05226117

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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: 7.5 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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan	Sacituzumab govitecan is a humanized monoclonal antibody (mAb) with a hydrolyzable linker through which SN-38 is conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- expressing tumors while reducing systemic toxicity. SN-38 is the active metabolite of irinotecan. Sacituzumab govitecan is administered at 7.5 mg/kg as an IV infusion on days 1 and 8 of a 21- day cycle till progression, toxicity or withdrawal of consent

Timeline

• Start date: 2022-03-23
• Primary completion: 2025-09-24
• Completion: 2025-09-24
• First posted: 2022-02-07
• Last updated: 2026-03-27

Locations

1 site across 1 country: Italy