drugset / Trial / NCT05304546
Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma
NaSingle-groupOpen-labelTreatment
Summary
This study will enroll metastatic (Stage IV or inoperable stage III) melanoma (MM) patients carrying a BRAF V600E/K mutation with confirmed primary resistance to standard of care immunotherapy (single agent PD-1 or a combination of CTLA-4/PD-1 blockade). Patients must be naïve to therapy with BRAF+MEK inhibitors, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Timeline
- Start
- 2023-09-05
- Primary completion
- 2025-07-17
- Completion
- 2025-07-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Binimetinib | Small molecule | 45 mg | Oral |
| Subject | Encorafenib | Small molecule | 450 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |