RecruitingPhase 2NCT05581589

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

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

Sponsor

University of Washington

Enrollment

18 participants

Start Date

Jun 15, 2023

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called sacituzumab govitecan given before bladder removal surgery in people with muscle-invasive bladder cancer that is not the standard type (non-urothelial). Researchers want to see if the drug can shrink the tumor before surgery, potentially improving outcomes. **You may be eligible if...** - You are 18 or older - You have muscle-invasive bladder cancer confirmed by biopsy or clinical assessment - Your cancer has not spread beyond the pelvis - You are scheduled for bladder removal surgery (radical cystectomy) - You are willing to give consent **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are unable to undergo surgery - Other medical conditions that your doctor determines make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELymphadenectomy

Undergo pelvic lymph node dissection

PROCEDURERadical Cystectomy

Undergo radical cystectomy

BIOLOGICALSacituzumab Govitecan

Given IV

Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT05581589