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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: A Pilot Single Arm Trial With Sacituzumab Govitecan as Neoadjuvant Therapy in Pts With Non-Urothelial Muscle Invasive Bladder Cancer

Study ID: NCT05581589

Conditions

Muscle Invasive Bladder Carcinoma

Stage II Bladder Cancer AJCC v8

Stage IIIA Bladder Cancer AJCC v8

Interventions

Lymphadenectomy

Radical Cystectomy

Sacituzumab Govitecan

Study Description

Brief 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.

Detailed Description: OUTLINE: Patients receive sacituzumab govitecan intravenously (IV) over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection. After completion of study treatment, patients are followed up at 1-3 months after radical cystectomy and then every 3-6 months for 2 years.