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- Title
A Phase II Trial of First-Line Combination Chemotherapy With Cisplatin, Pemetrexed, and Nivolumab for Unresectable Malignant Pleural Mesothelioma: A Study Protocol.
- Authors
Nobukazu Fujimoto; Keisuke Aoe; Toshiyuki Kozuki; Isao Oze; Katsuya Kato; Takumi Kishimoto; Katsuyuki Hotta; Fujimoto, Nobukazu; Aoe, Keisuke; Kozuki, Toshiyuki; Oze, Isao; Kato, Katsuya; Kishimoto, Takumi; Hotta, Katsuyuki
- Abstract
<bold>Background: </bold>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).<bold>Patients and Methods: </bold>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.<bold>Conclusion: </bold>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.
- Subjects
ANTINEOPLASTIC agents; CISPLATIN; CLINICAL trials; COMPARATIVE studies; EXPERIMENTAL design; LONGITUDINAL method; LUNG tumors; RESEARCH methodology; MEDICAL cooperation; MESOTHELIOMA; PROGNOSIS; RESEARCH; SURVIVAL; PLEURAL tumors; EVALUATION research
- Publication
Clinical Lung Cancer, 2018, Vol 19, Issue 5, pe705
- ISSN
1525-7304
- Publication type
journal article
- DOI
10.1016/j.cllc.2018.05.001