{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T16:00:11Z","timestamp":1793289611667,"version":"4.5.0"},"reference-count":49,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2023,2,1]],"date-time":"2023-02-01T00:00:00Z","timestamp":1675209600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Bristol Myers Squibb","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2022,12,30]]},"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>CheckMate 817, a phase 3B study, evaluated flat-dose nivolumab plus weight-based ipilimumab in patients with metastatic non-small cell lung cancer (NSCLC). Here, in this research, we report on first-line treatment in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0\u20131 (cohort A) and special populations (cohort A1: ECOG PS 2; or ECOG PS 0\u20131 with untreated brain metastases, renal impairment, hepatic impairment, or controlled HIV infection).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Cohorts A and A1 received nivolumab 240\u2009mg every 2 weeks plus ipilimumab 1\u2009mg\/kg every 6 weeks. The primary endpoint was the incidence of grade 3\u20134 and grade 5 immune-mediated adverse events (IMAEs; adverse events (AEs) deemed potentially immune-related, occurring &lt;100\u2009days of last dose, and treated with immune-modulating medication (except endocrine events)) and treatment-related select AEs (treatment-related AEs with potential immunological etiology requiring frequent monitoring\/intervention, reported between first dose and 30 days after the last dose) in cohort A; efficacy endpoints were secondary\/exploratory. In cohort A1, safety\/efficacy assessment was exploratory.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The most common grade 3\u20134 IMAEs were pneumonitis (5.1%), diarrhea\/colitis (4.9%), and hepatitis (4.6%) in cohort A (N=391) and diarrhea\/colitis (3.5%), hepatitis (3.5%), and rash (3.0%) in cohort A1 (N=198). The most common grade 3\u20134 treatment-related select AEs were hepatic (5.9%), gastrointestinal (4.9%), and pulmonary (4.6%) events in cohort A and gastrointestinal (4.0%), skin (3.5%), and endocrine (3.0%) events in cohort A1. No grade 5 IMAEs or treatment-related select AEs occurred. Treatment-related deaths occurred in 4 (1.0%) and 3 (1.5%) patients in cohorts A and A1, respectively. Three-year overall survival (OS) rates were 33.7% and 20.5%, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Flat-dose nivolumab plus weight-based ipilimumab was associated with manageable safety and durable efficacy in cohort A, consistent with data from phase 3 metastatic NSCLC studies. Special populations of cohort A1 including patients with ECOG PS 2 or ECOG PS 0\u20131 with untreated brain metastases had manageable treatment-related toxicity and clinically meaningful 3-year OS rate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02869789\">NCT02869789<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2022-006127","type":"journal-article","created":{"date-parts":[[2023,2,1]],"date-time":"2023-02-01T11:15:39Z","timestamp":1675250139000},"page":"e006127","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":62,"title":["First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct02869789","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4414-9432","authenticated-orcid":false,"given":"Neal E","family":"Ready","sequence":"first","affiliation":[{"name":"Department of Medicine, Duke University, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clarisse","family":"Audigier-Valette","sequence":"additional","affiliation":[{"name":"Division of Pneumo-Oncology, H\u00f4pital Sainte Musse, Toulon, Provence-Alpes-C\u00f4te d'Azur, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan W","family":"Goldman","sequence":"additional","affiliation":[{"name":"Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enriqueta","family":"Felip","sequence":"additional","affiliation":[{"name":"Oncology Department, Vall d\u2019Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tudor-Eliade","family":"Ciuleanu","sequence":"additional","affiliation":[{"name":"Department of Oncology, Oncology Institute Prof Dr Ion Chiricuta, Cluj-Napoca, Romania"},{"name":"University of Medicine and Pharmacy Iuliu Ha\u021bieganu, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Rosario Garc\u00eda Campelo","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, University Hospital A Coru\u00f1a (XXIAC-SERGAS), A Coru\u00f1a, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Jao","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology and Hematology, H\u00f4pital du Sacr\u00e9\u2010Coeur de Montr\u00e9al, Montr\u00e9al, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrice","family":"Barlesi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Aix-Marseille Universit\u00e9, CNRS, INSERM, CRCM, Assistance Publique-H\u00f4pitaux de Marseille (APHM), Marseille, Provence-Alpes-C\u00f4te d'Azur, France"},{"name":"Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phanie","family":"Bordenave","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Digestive Medical Oncology, Centre Hospitalier Universitaire de Nantes, Nantes, Pays de la Loire, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Rijavec","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Lombardia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laszlo","family":"Urban","sequence":"additional","affiliation":[{"name":"Onco-pulmonology Department, Matrahaza University and Teaching Hospital, Matrahaza, Heves, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-S\u00e9bastien","family":"Aucoin","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology and Hematology, Centre Int\u00e9gr\u00e9 Universitaire de Sant\u00e9 et de Services Sociaux de la Mauricie-et-du-Centre-du-Qu\u00e9bec, Trois-Rivi\u00e8res, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Zannori","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Azienda Ospedaliera Santa Maria di Terni, Terni, Umbria, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karim","family":"Vermaelen","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine, Ghent University Hospital, Ghent, Oost-Vlaanderen, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osvaldo","family":"Ar\u00e9n Frontera","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Centro de Investigaci\u00f3n Cl\u00ednica Bradford Hill, Santiago, RM, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Curioni Fontecedro","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology and Hematology, University Hospital Zurich, Zurich, Switzerland"},{"name":"Department of Oncology, University of Fribourg, Fribourg, Fribourg, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amparo","family":"S\u00e1nchez-Gastaldo","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Hospital Universitario \"Virgen del Rocio\", Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oscar","family":"Juan-Vidal","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hospital Polit\u00e9cnico y Universitario La Fe, Valencia, Comunidad Valenciana, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helena","family":"Linardou","sequence":"additional","affiliation":[{"name":"4th Oncology Department and Comprehensive Clinical Trials Centre, Metropolitan Hospital Athens, Athens, Attike, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Poddubskaya","sequence":"additional","affiliation":[{"name":"Clinical Center VitaMed, Moscow, Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R","family":"Spigel","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medical Oncology, Sarah Cannon Research Institute\/Tennessee Oncology, Nashville, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samreen","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Maio","sequence":"additional","affiliation":[{"name":"Department of Oncology, University of Siena and Center for Immuno-Oncology, University Hospital, Siena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunney","family":"Li","sequence":"additional","affiliation":[{"name":"Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, New Jersey, 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Available: https:\/\/www.nccn.org\/professionals\/physician_gls\/PDF\/nscl.pdf [Accessed 27 Jul 2022]."},{"key":"2025100313135135000_11.2.e006127.11","unstructured":"ESMO Guidelines Committee . Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. 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First-line nivolumab + ipilimumab + 2 cycles of chemotherapy vs chemotherapy alone (4 cycles) in patients with advanced NSCLC: 2-year update from checkmate 9LA (abstract 9000). 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