{"id":185,"date":"2021-06-30T14:45:16","date_gmt":"2021-06-30T14:45:16","guid":{"rendered":"https:\/\/mims.parabolasolution.com\/?page_id=185"},"modified":"2024-02-01T09:31:00","modified_gmt":"2024-02-01T01:31:00","slug":"study-design","status":"publish","type":"page","link":"https:\/\/bms.mimsit.net\/dosing\/1l-unresectable-malignant-pleural-mesothelioma\/study-design\/","title":{"rendered":"Study design: CheckMate 743 (unresectable malignant pleural mesothelioma)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"185\" class=\"elementor elementor-185\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-713af9e4 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"713af9e4\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c449420\" data-id=\"c449420\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3138bdf elementor-widget elementor-widget-text-editor\" data-id=\"3138bdf\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.5.5 - 03-02-2022 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#818a91;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#818a91;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>Phase 3, randomized, open-label trial in patients with unresectable malignant pleural mesothelioma<sup>1<\/sup><\/li>\n<li>Primary endpoint: OS<sup>1<\/sup><\/li>\n<li>Secondary endpoints: ORR, DCR, and PFS by BICR, PD-L1<sup>a<\/sup> expression as a predictive biomarker<sup>1<\/sup><\/li>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2996564b elementor-widget elementor-widget-text-editor\" data-id=\"2996564b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<figure class=\"wp-block-image size-full img-fluid d-none d-md-block\"><img decoding=\"async\" class=\"wp-image-186\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/checkmate_743_d.png\" alt=\"\" \/><\/figure>\n<!-- \/wp:image -->\n\n<!-- wp:image {\"id\":187,\"sizeSlug\":\"full\",\"linkDestination\":\"none\",\"className\":\"img-fluid d-block d-md-none\"} -->\n<figure class=\"wp-block-image size-full img-fluid d-block d-md-none\"><img decoding=\"async\" class=\"wp-image-187\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/checkmate_743_m.png\" alt=\"\" \/><\/figure>\n<!-- \/wp:image -->\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08652b0 elementor-widget elementor-widget-text-editor\" data-id=\"08652b0\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>*Although NIVO 3 mg\/kg Q2W is used in CheckMate 743, NIVO 360 mg Q3W is the regimen approved by the FDA. Flat dose approval is based on pharmacokinetic modeling and clinical subgroup efficacy and safety analyses. The benefits\/risk of NIVO 360 mg Q3W is expected to be similar to that of NIVO 3 mg\/kg Q2W.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-58b24ab elementor-widget elementor-widget-text-editor\" data-id=\"58b24ab\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><sup>a<\/sup>Determined by PD-L1 IHC 28-8 pharmDx assay from Dako. <sup>b<\/sup>Cisplatin (75 mg\/m<sup>2<\/sup>) or carboplatin (AUC 5) + pemetrexed (500 mg\/m<sup>2<\/sup>), Q3W for 6 cycles. Figure adapted from Baas et al. 2021.<sup>1<\/sup><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7374504 elementor-widget elementor-widget-text-editor\" data-id=\"7374504\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\tAUC, area under the curve; BICR, blinded independent central review; DCR, disease control rate; ECOG PS, Eastern Clinical Oncology Group Performance Status; FDA, US Food and Drug Administration; IHC, immunohistochemistry; IPI, ipilimumab; NIVO, nivolumab; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PD-L1, programmed death ligand 1; QxW, every x weeks; R, randomization.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3380432 elementor-widget elementor-widget-text-editor\" data-id=\"3380432\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t1. Baas PB, et al. <em>Lancet <\/em>2021;397:375\u2013386.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":173,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"page-template3.php","meta":{"footnotes":""},"class_list":["post-185","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/185","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/comments?post=185"}],"version-history":[{"count":25,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/185\/revisions"}],"predecessor-version":[{"id":1193,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/185\/revisions\/1193"}],"up":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/173"}],"wp:attachment":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/media?parent=185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}