drugset / Trial / NCT03563729
Melanoma Metastasized to the Brain and Steroids
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).
Timeline
- Start
- 2018-06-06
- Primary completion
- 2024-06-01
- Completion
- 2028-06-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Binimetinib | Small molecule | — | Oral |
| Subject | Dabrafenib | Small molecule | — | Oral |
| Subject | Encorafenib | Small molecule | — | Oral |
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Trametinib | Small molecule | — | Oral |