{"id":31,"date":"2021-06-28T15:29:53","date_gmt":"2021-06-28T15:29:53","guid":{"rendered":"https:\/\/mims.parabolasolution.com\/?page_id=31"},"modified":"2024-02-01T09:44:43","modified_gmt":"2024-02-01T01:44:43","slug":"study-design","status":"publish","type":"page","link":"https:\/\/bms.mimsit.net\/dosing\/metastatic-unresectable-melanoma\/study-design\/","title":{"rendered":"Study design: CheckMate 067 Study Design (melanoma)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"31\" class=\"elementor elementor-31\" 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-410bd5e6 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"410bd5e6\" 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-40253fa8\" data-id=\"40253fa8\" 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-bb11bc2 elementor-widget elementor-widget-text-editor\" data-id=\"bb11bc2\" 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, multicenter, double-blind study in patients with unresectable\/metastatic melanoma<sup>1<\/sup><\/li>\n<li>To compare NIVO + IPI or NIVO monotherapy with IPI monotherapy<sup>a,1<\/sup><\/li>\n<li>Co-primary endpoints<sup>a<\/sup>: PFS and OS in the NIVO-containing arms vs IPI monotherapy<sup>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-194d87ae elementor-widget elementor-widget-text-editor\" data-id=\"194d87ae\" 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-1217 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma.png\" alt=\"\" width=\"4116\" height=\"993\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma.png 4116w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-300x72.png 300w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-1024x247.png 1024w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-768x185.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-1536x371.png 1536w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-2048x494.png 2048w\" sizes=\"auto, (max-width: 4116px) 100vw, 4116px\" \/><\/figure>\n<figure class=\"wp-block-image size-full img-fluid d-block d-md-none\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1216 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-mobile.png\" alt=\"\" width=\"1785\" height=\"2979\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-mobile.png 1785w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-mobile-180x300.png 180w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-mobile-614x1024.png 614w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-mobile-768x1282.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-mobile-920x1536.png 920w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-067-Study-Design-melanoma-mobile-1227x2048.png 1227w\" sizes=\"auto, (max-width: 1785px) 100vw, 1785px\" \/><\/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-9cff64f elementor-widget elementor-widget-text-editor\" data-id=\"9cff64f\" 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>The study was not powered for a comparison of NIVO + IPI and NIVO.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c544d98 elementor-widget elementor-widget-text-editor\" data-id=\"c544d98\" 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 Larkin et al. 2019.<sup>1<\/sup>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c516ca elementor-widget elementor-widget-text-editor\" data-id=\"2c516ca\" 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\tAJCC, American Joint Committee on Cancer; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IPI, ipilimumab; NIVO, nivolumab; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; 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-fbfdf69 elementor-widget elementor-widget-text-editor\" data-id=\"fbfdf69\" 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. Larkin J, et al. <em>N Engl J Med<\/em> 2019;381:1535\u20131546.\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, multicenter, double-blind study in patients with unresectable\/metastatic melanoma1 To compare NIVO + IPI or NIVO monotherapy with IPI monotherapya,1 Co-primary endpointsa: PFS and OS in the NIVO-containing arms vs IPI monotherapy1 aThe study was not powered for a comparison of NIVO + IPI and NIVO.Figure adapted from Larkin et al. 2019.1 AJCC, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":15,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-template3.php","meta":{"footnotes":""},"class_list":["post-31","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/31","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=31"}],"version-history":[{"count":32,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/31\/revisions"}],"predecessor-version":[{"id":1220,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/31\/revisions\/1220"}],"up":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/15"}],"wp:attachment":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/media?parent=31"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}