{"id":588,"date":"2023-10-06T15:52:21","date_gmt":"2023-10-06T07:52:21","guid":{"rendered":"https:\/\/bms.mimsit.net\/dosing\/?page_id=588"},"modified":"2024-02-01T09:51:14","modified_gmt":"2024-02-01T01:51:14","slug":"study-design","status":"publish","type":"page","link":"https:\/\/bms.mimsit.net\/dosing\/1l-unresectable-advanced-recurrent-metastatic-escc\/study-design\/","title":{"rendered":"Study design: CheckMate 648 (ESCC)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"588\" class=\"elementor elementor-588\" 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-6ebcd1e7 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"6ebcd1e7\" 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-6bd8917\" data-id=\"6bd8917\" 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-c15fbac elementor-widget elementor-widget-text-editor\" data-id=\"c15fbac\" 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<ul>\n<li>Phase 3, randomized, open-label trial<sup>1<\/sup><\/li>\n<li>Primary endpoints: OS and PFS (by BICR)<sup>a<\/sup> in patients with tumor cell PD-L1 \u22651%<sup>1<\/sup><\/li>\n<li>Secondary endpoints: OS, PFS, ORR (by BICR)<sup>a,1<\/sup><\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a8ac359 elementor-widget elementor-widget-text-editor\" data-id=\"3a8ac359\" 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 loading=\"lazy\" decoding=\"async\" class=\"wp-image-590 size-full\" style=\"object-fit: cover;\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2023\/10\/eso-study.png\" alt=\"\" width=\"1828\" height=\"396\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2023\/10\/eso-study.png 1828w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2023\/10\/eso-study-300x65.png 300w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2023\/10\/eso-study-1024x222.png 1024w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2023\/10\/eso-study-768x166.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2023\/10\/eso-study-1536x333.png 1536w\" sizes=\"auto, (max-width: 1828px) 100vw, 1828px\" \/><\/figure>\n<figure class=\"wp-block-image size-full img-fluid d-block d-md-none\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1232 size-full\" style=\"object-fit: cover;\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/eso-study-mobile.png\" alt=\"\" width=\"1090\" height=\"1816\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/eso-study-mobile.png 1090w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/eso-study-mobile-180x300.png 180w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/eso-study-mobile-615x1024.png 615w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/eso-study-mobile-768x1280.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/eso-study-mobile-922x1536.png 922w\" sizes=\"auto, (max-width: 1090px) 100vw, 1090px\" \/><\/figure>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dc1c7e9 elementor-widget elementor-widget-text-editor\" data-id=\"dc1c7e9\" 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\tFigure adapted from Doki et al. 2022.<sup>1<\/sup>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-73511ab elementor-widget elementor-widget-text-editor\" data-id=\"73511ab\" 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<sup>a<\/sup>Per RECIST version 1.1; in patients with tumor cell PD-L1 \u22651% and then in all randomized patients. <sup>b<\/sup>Fluorouracil 800 mg\/m<sup>2<\/sup> (days 1\u20135) and cisplatin 80 mg\/m<sup>2<\/sup> (day 1).\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fbca9aa elementor-widget elementor-widget-text-editor\" data-id=\"fbca9aa\" 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>BICR, blinded independent central review; chemo, chemotherapy; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ESCC, esophageal squamous cell carcinoma; IPI, ipilimumab; NIVO, nivolumab; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; QxW, every x weeks; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors.<\/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-5880a9b elementor-widget elementor-widget-text-editor\" data-id=\"5880a9b\" 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. Doki Y, et al. <em>N Engl J Med<\/em> 2022;386:449-462.\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":"<p>Phase 3, randomized, open-label trial1 Primary endpoints: OS and PFS (by BICR)a in patients with tumor cell PD-L1 \u22651%1 Secondary endpoints: OS, PFS, ORR (by BICR)a,1 Figure adapted from Doki et al. 2022.1aPer RECIST version 1.1; in patients with tumor cell PD-L1 \u22651% and then in all randomized patients. bFluorouracil 800 mg\/m2 (days 1\u20135) and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":568,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-template3.php","meta":{"footnotes":""},"class_list":["post-588","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/588","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=588"}],"version-history":[{"count":25,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/588\/revisions"}],"predecessor-version":[{"id":1551,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/588\/revisions\/1551"}],"up":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/568"}],"wp:attachment":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/media?parent=588"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}