drugset / Trial / NCT05581589

Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer

NCT05581589 ↗

Phase 2 Terminated 4 enrolled University of Washington Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial tests whether sacituzumab govitecan given before radical cystectomy works in treating patients with non-urothelial bladder cancer. Sacituzumab govitecan contains a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan before radical cystectomy may make the surgery more effective in patients with muscle invasive bladder cancer.

Timeline

Start
2023-06-15
Primary completion
2024-10-15
Completion
2026-03-06

Outcome

Outcome not reported

Stopped (Enrollment): “Study closed to accrual before meeting accrual goal due to major enrollment challenges based on the very rare disease indication studied and rapid changes in the therapy landscape.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Sacituzumab Govitecan Monoclonal antibody — Intravenous