At a glance
ClinicalIndex Comparison Record- ✓Histologically documented metastatic or locally advanced unresectable urothelial cancer (T4b any N, or any T N2-3). Mixed histologic types allowed if urothelial predominant.
- ✓Progression or recurrence following platinum-containing regimen AND anti-PD-1/PD-L1 therapy for metastatic or locally advanced disease.
- ✓ECOG performance status 0 or 1.
- ✓Hemoglobin ≥9 g/dL, ANC ≥1,500/mm³, platelets ≥100,000/µL (without transfusion or growth factor support within 2 weeks).
- ✕Prior topoisomerase 1 inhibitors.
- ✕Active second malignancy (history completely treated ≥3 years prior is allowed).
- ✕Myocardial infarction, unstable angina, serious arrhythmia, QT prolongation, NYHA Class ≥III heart failure, or LVEF <40%.
- ✕Active chronic inflammatory bowel disease or GI perforation within 6 months.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer
In Brief
A Phase 3 clinical trial evaluating Sacituzumab Govitecan-hziy, Paclitaxel, and 2 other interventions for Locally Advanced or Metastatic Unresectable Urothelial Cancer. Completed, enrolled 711 participants across 234 sites in 27 countries.
Signals
Detailed Summary
The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).
Study Details
Timeline
Arms & Interventions
Participants will receive 10 mg/kg of SG intravenously (IV) on Day 1 and Day 8 of each 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met.
Participants will receive 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and will continue to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met. Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle (in countries where vinflunine was approved and was commercially available).
Interventions
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously