drugset / Trial / NCT04724018

Sacituzumab Govitecan Plus EV in Metastatic UC

NCT04724018

Phase 1/2 Recruiting 106 enrolled Dana-Farber Cancer Institute Gilead Sciences · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination. The names of the study drugs in these investigational combinations are: * Enfortumab Vedotin * Sacituzumab Govitecan * Pembrolizumab

Timeline

Start
2021-05-20
Primary completion
2027-02-01
Completion
2028-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Enfortumab Vedotin Other / unclassified 1.25 mg/kg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody 7.5 mg/kg Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody 8 mg/kg Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous