Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Trial
Official title:
A Phase 2 Study of Combination Treatment of Binimetinib and Nivolumab for Advanced V600BRAF Wildtype Melanoma With Innate Anti-PD-1 Resistance
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.
PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVE: 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 response (DOR). EXPLORATORY OBJECTIVE: 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 tumor biopsies. OUTLINE: 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. ;
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