drugset / Trial / NCT04863885
Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients
Phase 1/2
Active not recruiting
46 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb · collabGilead Sciences · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.
Timeline
- Start
- 2021-04-30
- Primary completion
- 2025-09-12
- Completion
- 2027-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |