Open Label Phase 2 Study Neo-Adjuvant BRAF/MEK Inhibition Followed by Surgery and Adjuvant BRAF/MEK Inhibition in In-transit Melanoma Metastases (NASAM)
Phase 2 open-label single arm intervention study administering encorafenib/binimetinib in neo-adjuvant setting followed by surgery and subsequent adjuvant encorafenib/binimetinib in in-transit melanoma patients without lymph node and distant metastases.
• Age over 18 years old
• World Health Organization (WHO) Performance Status 0 or I
• Primary cutaneous melanoma or unknown primary melanoma with pathologically confirmed in-transit metastatic melanoma
• Patients must have undergone complete disease staging including: PET-CT scan and MRI scan
• Patients must be medically fit to undergo surgery
• Patients must be able to take oral medication
• No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies)
• No prior radiotherapy to site of interest (surgical therapy is allowed; in order to obtain pathological information of the melanoma)
• Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH \< 2xULN. Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate \> 50 mL/min/1.73m2.
• Absence of additional severe and/or uncontrolled concurrent disease