Status:
Recruiting
Phase:
Phase III
Official Title:
Phase III Study of Sacituzumab Goveitecan in Metastatic or Locally Advanced Unresectable Urothelial Cancer
NCT ID:
NCT#04527991
Link to Full Details:
Description:
Tx Arms
Arm A: Sacituzumab govitecan IV days 1, 8 of a 21
day cycle
Arm B: Physician Choice-
Paclitaxel Q 21 days or Docetaxel Q 21 days
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Metastatic or locally advanced unresectable UC defined as: T4b, any N OR any T, N2-3
- Tumors of upper and lower tract are permitted
- Mixed histology types are allowed if urothelial is the predominant histology
- Patients with progression or recurrence following receipt of platinum- containing regimen and anti-PD-1/PD- L1 therapy for metastatic or locally advanced unresectable disease
Exclusion Criteria:
- Patients who have received prior chemo for urothelial cancer with all the available standard of care options in the control arm