Despite the significant progress in the treatment of unresectable or metastatic BRAF V600-mutant melanoma, there remains two primary treatment options: targeted therapy and immunotherapy. Targeted therapy or immunotherapy alone is associated with efficacy limitations including efficacy limited to select patient subsets. With separate mechanisms of action and different response patterns, the combination of targeted agents and immunotherapy to treat patients with BRAF V600-mutant melanoma may further improve patient outcomes. Current treatment guidelines recommend treatment with targeted agents alone, immunotherapy, or the combination of targeted agents and immunotherapy. The randomized, double-blind STARBOARD trial aims to evaluate efficacy and safety of encorafenib, binimetinib and pembrolizumab in treatment-naive patients with metastatic or unresectable locally advanced BRAF V600-mutant melanoma in comparison to pembrolizumab.
Trial registration: ClinicalTrials.gov NCT04657991.
Keywords: BRAF V600 mutations; advanced melanoma; binimetinib; encorafenib; immunotherapy; pembrolizumab; targeted therapy; triplet combination therapy.
Targeted therapy, including BRAF- and MEK-inhibitors, and immunotherapies have greatly contributed to advances in the treatment of BRAF-mutant melanoma. Additionally, immunotherapy in combination with targeted therapy has been shown to improve patient outcomes. In this study, the authors assess the efficacy and safety of a combination of a BRAF-inhibitor (encorafenib), an MEK-inhibitor (binimetinib) and an anti-PD-1 (pembrolizumab) in patients with metastatic BRAF-mutant melanoma. Clinical Trial Registration: NCT04657991 (ClinicalTrials.gov).