drugset / Trial / NCT03523572
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a study of trastuzumab deruxtecan for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: * Part 1 is to identify the recommended dose to use for treatment. * Part 2 is to find out how well the combination works, and how safe and tolerable it is.
Timeline
- Start
- 2018-08-02
- Primary completion
- 2021-07-22
- Completion
- 2023-09-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 3.2 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |