Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer

Patients with MIBC N0/N1 unwilling or unfit for cystectomy will receive SG + Zimberelimab for 3 cycles of treatment prior of first radiological and TURB re-evaluation. Patients with stable disease or downstaging will continue Zimberelimab up to 1 year. The goal of this trial is to demonstate that Sacituzumab Govitecan + Zimberelimab can avoid cistectomy and can prolong or avoid recurrence to metastatic disease in selected patients with muscle-invasive bladder cancer. The primary endpoint of this trial is Event Free Survival that is defined as clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event.

NCT Number	NCT06528483
Lead Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Collaborators: Gilead Sciences
Conditions	Bladder Cancer, Bladder Urothelial Carcinoma, Bladder Neoplasm, Muscle-Invasive Bladder Carcinoma
Enrollment	63 participants
Start Date	2024-12-02
Primary Completion	2026-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-07-30