CHECKMATE 9LA STUDY DESIGN TRIAL
CHECKMATE 9LA STUDY DESIGN PLUS

The median follow-up in surviving patients in both groups was 29.5 months (95% CI, 26.0-32.8 months).

CHECKMATE 9LA STUDY DESIGN TRIAL

All rights reserved.252 patients enrolled in the Phase 3 trial from 58 institutions in the US through the National Clinical Trial network and were randomized 1:1 to nivolumab or the combination of nivolumab-ipilimumab.

CHECKMATE 9LA STUDY DESIGN PLUS

Nivolumab plus ipilimumab provided significant and clinically meaningful improvements in overall survival versus standard-of-care chemotherapy, supporting the use of this first-in-class regimen that has been approved in the USA as of October, 2020, for previously untreated unresectable MPM.Ĭopyright © 2021 Elsevier Ltd. Three (1%) treatment-related deaths occurred in the nivolumab plus ipilimumab group (pneumonitis, encephalitis, and heart failure) and one (<1%) in the chemotherapy group (myelosuppression). Grade 3-4 treatment-related adverse events were reported in 91 (30%) of 300 patients treated with nivolumab plus ipilimumab and 91 (32%) of 284 treated with chemotherapy. 2-year overall survival rates were 41% (95% CI 35♱-46♵) in the nivolumab plus ipilimumab group and 27% (21♹-32♴) in the chemotherapy group. At the prespecified interim analysis (database lock Apmedian follow-up of 29♷ months ), nivolumab plus ipilimumab significantly extended overall survival versus chemotherapy (median overall survival 18♱ months vs 14♱ months hazard ratio 0♷4 p=0♰020). 467 (77%) of 605 participants were male and median age was 69 years (IQR 64-75). This study is registered with, NCT02899299, and is closed to accrual.īetween Nov 29, 2016, and April 28, 2018, 713 patients were enrolled, of whom 605 were randomly assigned to either nivolumab plus ipilimumab (n=303) or chemotherapy (n=302). The primary endpoint was overall survival among all participants randomly assigned to treatment, and safety was assessed in all participants who received at least one dose of study treatment. Eligible participants were randomly assigned (1:1) to nivolumab (3 mg/kg intravenously once every 2 weeks) plus ipilimumab (1 mg/kg intravenously once every 6 weeks) for up to 2 years, or platinum plus pemetrexed chemotherapy (pemetrexed plus cisplatin or carboplatin ) once every 3 weeks for up to six cycles. Eligible individuals were aged 18 years and older, with previously untreated, histologically confirmed unresectable MPM, and an Eastern Cooperative Oncology Group performance status of 0 or 1. This open-label, randomised, phase 3 study (CheckMate 743) was run at 103 hospitals across 21 countries. We hypothesised that this regimen would improve overall survival in MPM. Nivolumab plus ipilimumab has shown clinical benefit in other tumour types, including first-line non-small-cell lung cancer. 19 Bichat-Claude Bernard University Hospital, AP-HP, Université de Paris, Paris, France.Īpproved systemic treatments for malignant pleural mesothelioma (MPM) have been limited to chemotherapy regimens that have moderate survival benefit with poor outcomes.18 Bristol Myers Squibb, Princeton, NJ, USA.17 Centro Oncológico, Médica Sur-Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.16 Department of Lung Cancer and Chest Tumours, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.15 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.14 Aix Marseille University, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.13 Erasmus MC Cancer Institute, Rotterdam, Netherlands.12 Centro Médico Nacional Siglo XXI, Mexico City, Mexico.

11 Hôpital Côte de Nacre CHU de Caen, Caen, France.10 H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.9 UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.8 Royal Marsden Hospital, London, UK Institute of Cancer Research, London, UK.6 MD Anderson Cancer Center, Houston, TX, USA.5 Lausanne University Hospital, Lausanne, Switzerland.4 Okayama Rosai Hospital, Okayama, Japan.3 Medical School, University of Western Australia Perth, WA, Australia Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.

Electronic address: 2 Pulmonary and Thoracic Oncology, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France.

1 The Netherlands Cancer Institute and Leiden University Medical Center, Amsterdam, Netherlands.

Checkmate 9la study design