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The rationale for this study comes from preclinical models, in which lenvatinib decreased the tumor-associated macrophage (TAM) population, which is known as an immune-regulator in the tumor microenvironment. The decrease in TAM population was accompanied by an increase in activated cytotoxic T-cell populations through stimulation of interferon-gamma signaling, resulting in increased immune activation This immune-modulating effect of lenvatinib may result in a potent combination effect with PD-1/L1 signal inhibitors.
APhase 1b/2 study to assess the safety and preliminary antitumor activity of the combination of lenvatinib plus pembrolizumab in participants with selected solid tumors determined the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) as 20 mg lenvatinib QD in combination with 200 mg of pembrolizumab given intravenously (IV) every 3 weeks (Q3W). This phase II study will generate further data on safety and efficacy of the combination of lenvatinib and pembrolizumab in different cohorts of participants with triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, glioblastoma and biliary tract cancers.