drugset / Trial / NCT04724018
Sacituzumab Govitecan Plus EV in Metastatic UC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |