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

Study acronym: preSAVE
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06528483
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators: Gilead Sciences
Conditions
(from sponsor)		 Bladder Cancer, Bladder Urothelial Carcinoma, Bladder Neoplasm, Muscle-Invasive Bladder Carcinoma
Related terms Urinary Bladder Neoplasms
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov