Safety and Feasibility of Sacituzumab Govitecan with Adaptive Radiation Therapy for Bladder Preservation in Muscle-Invasive Bladder Cancer

What this Trial Is About

This research aims to evaluate the safety and tolerability of combining Sacituzumab Govitecan SG with adaptive image-guided radiation therapy for bladder preservation in participants with localized muscle-invasive bladder cancer MIBC. The study focuses on participants who are not eligible for or refuse radical cystectomy and conventional chemotherapy, seeking a bladder-sparing treatment approach. SG is an investigational antibody-drug conjugate designed to target bladder cancer cells, and this Phase 1 study investigates its use along with radiation therapy in this specific population. Participants receive SG intravenously at 8 mgkg once weekly on days 1 and 8 of each 21-day cycle. The first cycle of SG starts 21 days before radiation therapy begins, while the second and third cycles are given concurrently with adaptive radiotherapy tailored individually. The study involves up to three cycles of SG with concurrent radiation. This treatment period lasts approximately 8 weeks. During the study, participants undergo computed tomography CT and magnetic resonance imaging MRI before and after treatment to assess response. Researchers monitor safety by tracking acute dose-limiting toxicities within 6 months and evaluate bladder intact event-free survival over 2 years. Follow-up includes up to 2 to 5 years of monitoring, with survival follow-up by phone during years 3 to 5, allowing assessment of long-term outcomes and treatment feasibility.

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer