OncoMatch/Clinical Trials/NCT05581589
Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer
Is NCT05581589 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab Govitecan for muscle invasive bladder carcinoma.
Treatment: Sacituzumab Govitecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CT2-T4AN0-N1M0, CT1-4AN1M0 (AJCC)
Excluded: Stage CT4B, CN2, CN3
cT2-T4aN0-N1M0 or cT1-4aN1M0 clinical stage per American Joint Commission on Cancer [AJCC]; Known locally advanced (unresectable, e.g. cT4b) or metastatic (cN2-3, M1) cancer on baseline radiographic imaging (CT or MRI) obtained within 28 days prior to registration [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Prior systemic anti-cancer therapy, including investigational agent/device within 4 weeks
Cannot have received: radiation therapy
prior radiation therapy within 2 weeks
Cannot have received: topoisomerase-1 inhibitor (irinotecan, topotecan)
prior systemic irinotecan or topotecan or other topoisomerase-1 inhibitor
Lab requirements
Blood counts
ANC >= 1500/uL; Platelets >= 100,000/uL; Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks prior to study drug treatment)
Kidney function
Serum creatinine <= 1.5 x ULN OR measured or calculated creatinine clearance >= 30 ml/min (GFR can be used in place of creatinine clearance; 24-hour urine collection can be used for more accurate estimate as needed)
Liver function
Total bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 x ULN; AST and ALT <= 2.5 x ULN
ANC >= 1500/uL; Platelets >= 100,000/uL; Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L; Serum creatinine <= 1.5 x ULN OR measured or calculated creatinine clearance >= 30 ml/min; Total bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 x ULN; AST and ALT <= 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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