Locally advanced or metastatic melanoma
Conditions
Interventions
Patients will follow standard of care treatment following national guidelines for their cancer as prescribed by their treating oncologist. The only intervention is additional blood collection during r
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age over 18 years oldPrimary cutaneous melanoma or unknown primary melanoma with pathologically confirmed irresectable stage III and IV metastatic melanomaHistologically confirmed presence of BRAFV600E/K mutation in primary tumor tissuePatients must have undergone complete disease staging including: PET-CT scan and MRI scanPatients must be able to take oral medicationNo prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies), except for the use of (neo)adjuvant treatment for resectable stage III melanoma more than 6 months ago
Exclusion criteria
Exclusion criteria: Current treatment with antiretroviral drugs, herbal remedies and drugs that are strong inhibitors or inducers of CYP3A and CYP2C8, CYP2C9, CYP2C19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is ctDNA dynamics over time | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression free survival (PFS) - Overall survival (OS)- Time to drug resistance- Toxicity according to CTCAE 5.0- Incidence and time of/to discontinuation- Number of dose adjustments- Response rate (RECIST 1.1)- Drug exposure - ctDNA relationship- Population pharmacokinetics of Encorafenib/Binimetinib - Extracellular Vesicles derived ctDNA dynamics over time- Sensitivity mutation detection techniques (NGS, panel, dPCR) | — |
Countries
Netherlands
Contacts
Public ContactH.W. Kapiteijn Ellen
Leids Universitair Medisch Centrum
Outcome results
None listed