A Phase II Neoadjuvant Study of Encorafenib with Binimetinib in Patients with Resectable Locoregional Metastases from Cutaneous or Unknown Primary Melanoma (Stages III NIB/C/D)

This is a single-arm phase II trial that aims to determine how well encorafenib, a selective BRAF inhibitor, and binimetinib, a MEK inhibitor, work before surgery in treating patients with BRAF V600-mutated stage IIIB-D melanoma that has spread to the lymph nodes. The trial is also assessing how well 18F-FLT positron emission tomography (PET)/computed tomography (CT) works in predicting the response of melanoma to encorafenib and binimetinib.

The primary endpoint is pathologic complete response (pCR) as determined by a local assessment of surgical pathologic specimens and radiology studies. Additionally, the trial will include a radiologic key secondary endpoint with a molecular imaging marker FLT PET, designed to test an early response indicator that could be used to guide BRAF/MEK targeted therapy. FLT-PET scans will be evaluated at two time points (baseline and eight weeks after therapy initiation) and correlated with pCR.

This study is led by Leslie A. Fecher, MD (University of Michigan).

Learn more about EA6183 at ecog-acrin.org.