Phase 2 Study of Sacituzumab Govitecan Alone and in Combination for Advanced or Metastatic Urothelial Cancer

What this Trial Is About

Researchers are evaluating sacituzumab govitecan-hziy alone and in combination with other therapies for people with metastatic urothelial cancer mUC that cannot be removed or has spread. The study aims to assess how well these treatments work and their safety. This is a Phase II open-label trial sponsored by Gilead Sciences, including multiple cohorts with different treatment plans to better understand the effects in various patient groups. Participants receive sacituzumab govitecan-hziy intravenously on Days 1 and 8 of a 21-day cycle, alone or combined with other drugs like pembrolizumab, cisplatin, avelumab, zimberelimab, and others depending on the cohort. Some cohorts receive combinations with chemotherapy drugs such as carboplatin and gemcitabine, with dose adjustments based on tolerability. Maintenance therapies involving avelumab or zimberelimab may follow initial treatment cycles if the disease does not progress. During the study, participants undergo regular imaging scans such as CT or MRI to measure tumor response following RECIST 1.1 criteria. Researchers monitor treatment responses, progression-free survival, overall survival, and adverse events through scheduled visits and assessments for up to two years after treatment. Laboratory tests and safety monitoring occur throughout the treatment and follow-up periods, with continued tumor evaluation even if treatment stops before progression is confirmed.

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread