This phase II trial studies how well binimetinib and nivolumab work in treating patients with
BRAF V600 wildtype melanoma that has spread to nearby tissues or lymph nodes and cannot be
removed by surgery (locally advanced unresectable) or has spread to other places in the body
(metastatic). Binimetinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help
the body's immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. Giving binimetinib and nivolumab together may work better in treating
patients with melanoma compared to nivolumab alone.
I. Objective response rate (ORR), which is defined as the proportion of response-evaluable
participants either with a confirmed complete response (CR) or partial response (PR) per
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the investigator
assessment, at best overall response.
I. Progression-free survival (PFS), clinical benefit rate (CR + PR + stable disease [SD]
among response-evaluable participants, per RECIST 1.1), overall survival (OS) and duration of
I. Evaluation of histologic evidence of response (p-ERK reduction in residual tumor cells and
CD8 T cell or tumor infiltrating lymphocytes or tumor infiltrating lymphocyte [TIL]
infiltration induced by combination treatment) using pretreatment and early on-treatment
Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and nivolumab
intravenously (IV) over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12
cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 1
year, then annually thereafter.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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