Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

Summary

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

Timeline

Start

2016-11-29

Primary completion

2020-03-25

Completion

2023-04-28

Outcome

Met primary endpoint

paper nivolumab plus ipilimumab significantly extended overall survival versus chemotherapy (median overall survival 18·1 months PMID 33485464 ↗

registry analysis (superiority test); Treatment A vs Treatment B; p = 0.0020; Hazard Ratio (HR) 0.74 (96.6% CI 0.60 to 0.91) NCT02899299 ↗

Publications

• Scherpereel A, Baas P, Nowak AK, Tsao AS, Fujimoto N, Peters S, Mansfield AS, Popat S, Bautista Aragon Y, Talbot T, Grossi F, Kowalski D, Kaplan MA, Cardona AF, Soomro R, Hu N, Lee A, Ip V, Hung YH, Zalcman G. Five-Year Clinical Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Unresectable Pleural Mesothelioma in CheckMate 743. J Clin Oncol. 2026 Mar 20;44(9):742-749. doi: 10.1200/JCO-25-01328. Epub 2026 Feb 24.
• Scherpereel A, Antonia S, Bautista Y, Grossi F, Kowalski D, Zalcman G, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Sun X, Lawrance R, Zhang X, Daumont MJ, Bennett B, McKenna M, Baas P. First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743. Lung Cancer. 2022 May;167:8-16. doi: 10.1016/j.lungcan.2022.03.012. Epub 2022 Mar 21.
• Peters S, Scherpereel A, Cornelissen R, Oulkhouir Y, Greillier L, Kaplan MA, Talbot T, Monnet I, Hiret S, Baas P, Nowak AK, Fujimoto N, Tsao AS, Mansfield AS, Popat S, Zhang X, Hu N, Balli D, Spires T, Zalcman G. First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743. Ann Oncol. 2022 May;33(5):488-499. doi: 10.1016/j.annonc.2022.01.074. Epub 2022 Feb 3.
• Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Jahan T, Antonia S, Oulkhouir Y, Bautista Y, Cornelissen R, Greillier L, Grossi F, Kowalski D, Rodriguez-Cid J, Aanur P, Oukessou A, Baudelet C, Zalcman G. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386. doi: 10.1016/S0140-6736(20)32714-8. Epub 2021 Jan 21.
• Wright K. FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma. Oncology (Williston Park). 2020 Nov 12;34(11):502-503. doi: 10.46883/ONC.2020.3411.0502.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	5 unknown	Intravenous
Comparator	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Comparator	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Indications