TY - JOUR
T1 - A Phase II Trial of First-Line Combination Chemotherapy With Cisplatin, Pemetrexed, and Nivolumab for Unresectable Malignant Pleural Mesothelioma
T2 - A Study Protocol
AU - Fujimoto, Nobukazu
AU - Aoe, Keisuke
AU - Kozuki, Toshiyuki
AU - Oze, Isao
AU - Kato, Katsuya
AU - Kishimoto, Takumi
AU - Hotta, Katsuyuki
N1 - Funding Information:
Dr Fujimoto has received consultancy fees from Boehringer Ingelheim, Bristol-Myers Squibb, Kyorin, and Kissei, and received honoraria or research funding from Hisamitsu, Chugai, Ono, Taiho, Boehringer Ingelheim, Bristol-Myers Squibb, Novartis, GlaxoSmithKline, and MSD. Dr Aoe has received consultancy fees from Boehringer Ingelheim, Bristol-Myers Squibb, Ono, and received honoraria or research funding from Ono, Bristol-Myers Squibb, Novartis, MSD, AstraZeneca, and Eli Lilly. Dr Kozuki has received honoraria or research funding from Chugai, AstraZeneca, Eli Lilly, Pfizer, Ono, Boehringer Ingelheim, Bristol-Myers Squibb, Kyowa, Taiho, MSD, Merck, and Nippon Kayaku. Dr Hotta has received honoraria or research funding from AstraZeneca, Ono, Boehringer Ingelheim, Nippon Kayaku, Taiho, Chugai, Astellas, Novartis, Bristol-Myers Squibb, Eli Lilly, and MSD. The remaining authors have stated that they have no conflicts of interest.
Funding Information:
This study is supported by a grant from Ono Pharmaceutical Co, Ltd, and also by grants-in-aid from the Ministry of Health, Labor, and Welfare, Japan. Nivolumab was kindly provided by Ono Pharmaceutical Co, Ltd.
Publisher Copyright:
© 2018 The Author(s)
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2018/9
Y1 - 2018/9
N2 - Background: 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 and Methods: 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/m 2 ), pemetrexed (500 mg/m 2 ), 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. Conclusion: 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.
AB - Background: 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 and Methods: 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/m 2 ), pemetrexed (500 mg/m 2 ), 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. Conclusion: 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.
KW - Asbestos
KW - Immune checkpoint inhibitor
KW - Maintenance
KW - Programmed death-1
KW - Prospective study
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U2 - 10.1016/j.cllc.2018.05.001
DO - 10.1016/j.cllc.2018.05.001
M3 - Article
C2 - 29853412
AN - SCOPUS:85047492553
VL - 19
SP - e705-e707
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 5
ER -