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

Our plain-English summary of A Phase II Trial of First-Line Combination Chemotherapy With Cisplatin, Pemetrexed, and Nivolumab for Unresectable Malignant Pleural Mesothelioma: A Study Protocol, by N. Fujimoto, K. Aoe, T. Kozuki, et al (Clinical Lung Cancer, 2018).

The study

• Authors: N. Fujimoto, K. Aoe, T. Kozuki, I. Oze, K. Kato, T. Kishimoto, K. Hotta
• Journal: Clinical Lung Cancer
• Published: 2018;19(5):e705-e707
• Cited by: 20 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

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.

Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.

In plain English

This article is a study protocol. It describes a clinical trial that had just started, and it reports no patient results. The trial was planned as a single-arm, prospective, non-randomized, open-label phase II trial at several centers. The plan was to enroll 18 patients from four Japanese institutions within one year. Patients were to have malignant pleural mesothelioma that was untreated, advanced or metastatic, and unresectable, meaning it could not be removed by surgery. Each patient was to receive three drugs together every 3 weeks for 4 to 6 cycles: cisplatin, pemetrexed, and nivolumab, a drug that blocks the PD-1 immune checkpoint. Patients whose disease had not progressed during this combination phase would then continue on nivolumab alone. This would last until their disease progressed, side effects became unacceptable, or they met the criteria for leaving the study. The article does not study asbestos exposure. The authors stated that the trial began in January 2018. They described it as the first prospective trial to test an anti-PD-1 antibody combined with cisplatin and pemetrexed for unresectable malignant pleural mesothelioma.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Study protocol for a single-arm, prospective, non-randomized, non-comparative, open-label, multicenter phase II clinical trial
• Who was studied: Planned enrollment of 18 patients with untreated, advanced or metastatic, unresectable malignant pleural mesothelioma at four Japanese institutions within 1 year
• Exposure: Not asbestos exposure. The trial treatment was cisplatin, pemetrexed and nivolumab given together every 3 weeks for 4 to 6 cycles. Patients whose disease had not progressed during this combination phase would then receive nivolumab maintenance until disease progression, unacceptable toxicity, or withdrawal criteria were met.
• The authors' conclusion: The authors stated that the trial began in January 2018 and was the first prospective trial to evaluate an anti-PD-1 antibody combined with cisplatin and pemetrexed for unresectable malignant pleural mesothelioma

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Chemotherapy, Cisplatin, Pemetrexed (Alimta), Nivolumab (Opdivo), Unresectable, Pleural Mesothelioma, Disease Progression, Overall Survival.

Related studies

• Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial — G.L. Ceresoli, J.G. Aerts, et al. (2019)
• Phase I Trial of Cediranib in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Unresectable Malignant Pleural Mesothelioma (SWOG S0905) — A.S. Tsao, J. Moon, et al. (2017)
• Phase I trial of cisplatin, pemetrexed, and imatinib mesylate in chemonaive patients with unresectable malignant pleural mesothelioma — A.S. Tsao, N. Harun, et al. (2014)
• A phase 1b clinical trial of the CD40-activating antibody CP-870,893 in combination with cisplatin and pemetrexed in malignant pleural mesothelioma — A.K. Nowak, A.M. Cook, et al. (2015)
• A Phase II Trial of Nivolumab With Chemotherapy Followed by Maintenance Nivolumab in Patients With Pleural Mesothelioma After Surgery: The NICITA Study Protocol — R. Shah, L.V. Klotz, et al. (2021)
• First-line chemotherapy with pemetrexed plus cisplatin for malignant peritoneal mesothelioma — E. Fujimoto, T. Kijima, et al. (2017)

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