Background: In pleural mesothelioma (PM), platinum-based chemotherapy and immune checkpoint inhibitors including nivolumab and ipilimumab have been approved but have not shown sufficient therapeutic efficacy, and the development of new therapies is desired. Pembrolizumab, anti-PD-1 antibody and lenvatinib which has inhibitory effect of angiogenesis are also expected to have a therapeutic effect on PM.
Patients and methods: Twenty-five patients will be enrolled in PENINSULA trial. In induction treatment, study interventions include oral lenvatinib, 8 mg QD, and pembrolizumab, 200 mg, carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2), and pemetrexed, 500 mg/m2 all given by intravenous (IV) infusion. In maintenance treatment, participants may receive lenvatinib, 20 mg QD, and pembrolizumab, 200 mg. Lenvatinib and pembrolizumab may be given for up to a total of 35 courses. The primary endpoint is overall response rate. The secondary endpoints are progression-free survival, overall survival time, tumor shrinkage (disease control rate), duration of response, best overall response and safety evaluation.
Conclusion: The purpose of this clinical trial is to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab and standard chemotherapy as first-line therapy in adult patients with PM.
Keywords: Combination therapy; Immune checkpoint inhibitor; Multicenter study; Multikinase inhibitors; Phase II trial.
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