P2.06-10 Combination Chemotherapy with Cisplatin, Pemetrexed, and Nivolumab for Malignant Pleural Mesothelioma: A Trial in Progress

Abstract

Combination chemotherapy with cisplatin and pemetrexed is the standard treatment regimen for malignant pleural mesothelioma (MPM); however, the median overall survival (OS) is just about 12 months. Additional treatment options are urgently needed. The aim of this study is to assess the efficacy and safety of combination chemotherapy with cisplatin, pemetrexed, and nivolumab for unresectable MPM. This is a single-arm, prospective, non-randomized, non-comparative, open label, multicenter, phase II trial. This study will assess the efficacy and safety of the first-line combination therapy of cisplatin, pemetrexed, and nivolumab for advanced or metastatic MPM. Key inclusion criteria includes 1) age older than 20 years, 2) pathologically-confirmed MPM, 3) measurable lesion designated by modified RECIST criteria, 4) tumor sample available to test for Programmed Death-Ligand 1 (PD-L1) expression, 5) Eastern Cooperative Oncology Group Performance Status is 0 or 1. Combination chemotherapy with cisplatin (75 mg/m2), pemetrexed (500 mg/m2), and nivolumab (360 mg/body) is administered every 3 weeks for a total of 4 to 6 cycles. Then, maintenance therapy with nivolumab will be administered until disease progression, unacceptable toxicities, or the patient’s condition meets the withdrawal criteria. The primary endpoint is the centrally-reviewed overall response rate. The secondary endpoints include the disease control rate, overall survival, progression-free survival. Safety and adverse events will also be evaluated. This phase II trial commenced in January 2018. A total of 18 patients will be enrolled from four Japanese institutions within 1 year. This is the first prospective trial to evaluate the effect of an anti-PD-1 antibody combined with cisplatin and pemetrexed for unresectable MPM. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000030892.