Abstract
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/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. 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.
| Original language | English |
|---|---|
| Journal | Clinical Lung Cancer |
| DOIs | |
| Publication status | Accepted/In press - Jan 1 2018 |
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Keywords
- Asbestos
- Immune checkpoint inhibitor
- Maintenance
- Programmed death-1
- Prospective study
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
- Cancer Research
Cite this
A Phase II Trial of First-Line Combination Chemotherapy With Cisplatin, Pemetrexed, and Nivolumab for Unresectable Malignant Pleural Mesothelioma : A Study Protocol. / Fujimoto, Nobukazu; Aoe, Keisuke; Kozuki, Toshiyuki; Oze, Isao; Kato, Katsuya; Kishimoto, Takumi; Hotta, Katsuyuki.
In: Clinical Lung Cancer, 01.01.2018.Research output: Contribution to journal › Article
}
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
PY - 2018/1/1
Y1 - 2018/1/1
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/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. 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/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. 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
UR - http://www.scopus.com/inward/record.url?scp=85047492553&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85047492553&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2018.05.001
DO - 10.1016/j.cllc.2018.05.001
M3 - Article
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
ER -