A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
Gilead Sciences
Summary
The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
Description
Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5, 6, and 7. Cohort 5 has been cancelled, effective December 2023.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: Inclusion Criteria for All Cohorts: * Female or male individuals, ≥ 18 years of age (19 Years old for South Korea). * Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1. * Adequate renal and hepatic function. * Adequate hematologic parameters without transfusional support. * Individuals must have a 3-month life expectancy. Additional Inclusion Criteria for Cohorts 1 to 6: * Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin): 1. Received a first-lin…
Interventions
- DrugSacituzumab Govitecan-hziy
Administered intravenously.
- DrugPembrolizumab
Administered per package insert
- DrugCisplatin
Administered per package insert
- DrugAvelumab
Administered per package insert
- DrugZimberelimab
Administered intravenously
- DrugCarboplatin
Administered per package insert
- DrugGemcitabine
Administered per package insert
Locations (135)
- The University of Arizona Cancer Center-North CampusTucson, Arizona
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Rocky Mountain Cancer CentersLittleton, Colorado
- Smilow Cancer Hospital at Yale-New HavenNew Haven, Connecticut
- Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut