Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer
NCT05581589 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2026-04-27
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.
Conditions
- Muscle Invasive Bladder Carcinoma
- Stage II Bladder Cancer AJCC v8
- Stage IIIA Bladder Cancer AJCC v8
Interventions
- PROCEDURE
-
Lymphadenectomy
Undergo pelvic lymph node dissection
- PROCEDURE
-
Radical Cystectomy
Undergo radical cystectomy
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Petros Grivas · Fred Hutch/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-15
- Primary Completion
- 2024-10-15
- Completion
- 2026-03-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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