A Phase II Trial of First-Line Combination Chemotherapy With Cisplatin, Pemetrexed, and Nivolumab for Unresectable Malignant Pleural Mesothelioma: A Study Protocol

Clinical Lung Cancer
Nobukazu FujimotoKatsuyuki Hotta

Abstract

The purpose of this study is to assess the efficacy and safety of combination chemotherapy with cisplatin, pemetrexed, and nivolumab for unresectable malignant pleural mesothelioma (MPM). Patients with untreated, advanced, or metastatic MPM who meet the inclusion and exclusion criteria will be included. A total of 18 patients will be enrolled from 4 Japanese institutions within 1 year. Combination chemotherapy with cisplatin (75 mg/m2), pemetrexed (500 mg/m2), and nivolumab (360 mg/person) 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 end point is the centrally reviewed overall response rate. The secondary end points include the disease control rate, overall survival, progression-free survival, and adverse events. This phase II trial evaluating first-line combination chemotherapy for unresectable MPM commenced in January 2018. This is the first prospective trial to evaluate the effect of an anti-programmed death-1 antibody combined with cisplatin and pemetrexed for unresectable MPM.

Citations

Jan 5, 2019·Annals of Oncology : Official Journal of the European Society for Medical Oncology·K M HeinhuisJ H M Schellens
Dec 12, 2019·Expert Opinion on Biological Therapy·Katsuyuki HottaKatsuyuki Kiura
Feb 27, 2020·Journal for Immunotherapy of Cancer·Katsuyuki Hotta, Nobukazu Fujimoto
Sep 8, 2020·Asia-Pacific Journal of Clinical Oncology·Takashi NakanoMasataka Hirabayashi
Apr 1, 2020·Frontiers in Oncology·Luca CantiniJoachim G J V Aerts
Jul 16, 2019·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Yuki AmanoTaichi Ito
Jan 29, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·K M HeinhuisJ H M Schellens
Jul 3, 2021·Cancers·Rita TerenzianiMara Bonelli
Nov 30, 2018·Chemical Reviews·Bernhard EnglingerWalter Berger

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