Pembrolizumab Plus Platinum Doublet Chemotherapy With Lenvatinib in Unresectable Pleural Mesothelioma as First-Line Treatment (PENINSULA): A Study Protocol for a Single-Arm, Multi-Institutional, Phase II Clinical Trial.

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.