{"id":221,"date":"2021-06-30T15:07:27","date_gmt":"2021-06-30T15:07:27","guid":{"rendered":"https:\/\/mims.parabolasolution.com\/?page_id=221"},"modified":"2026-04-07T11:12:06","modified_gmt":"2026-04-07T03:12:06","slug":"study-design","status":"publish","type":"page","link":"https:\/\/bms.mimsit.net\/dosing\/1l-advanced-hcc\/study-design\/","title":{"rendered":"Study designs"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"221\" class=\"elementor elementor-221\" 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-1e640b00 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"1e640b00\" 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-2c562f50\" data-id=\"2c562f50\" 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-aec4efa elementor-widget elementor-widget-text-editor\" data-id=\"aec4efa\" 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<h2>CheckMate 9DW (Phase 3)<sup>1<\/sup><\/h2>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bbe5006 elementor-widget elementor-widget-text-editor\" data-id=\"bbe5006\" 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<ul>\n<li>Phase 3, randomised, open-label study investigating nivolumab plus ipilimumab in a first line setting in patients with unresectable HCC without previous systemic therapy<sup>1<\/sup><\/li>\n<li>Primary endpoints: OS<sup>1<\/sup><\/li>\n<li>Secondary endpoints: ORR, DOR, TTD<sup>1<\/sup><\/li>\n<li>Exploratory endpoints: safety, PFS, TTR per BICR, ORR and PFS on next-line therapy, HRQoL, influence of PD-L1 on overall survival<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-c0afbec elementor-widget elementor-widget-text-editor\" data-id=\"c0afbec\" 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-1211 size-full\" style=\"width: 100%;\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2026\/04\/1l-advanced-hcc-study-design-fig-2-apr-1.png\" alt=\"\" \/><\/figure>\n<figure class=\"wp-block-image size-full img-fluid d-block d-md-none\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1212 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2026\/04\/1l-advanced-hcc-study-design-fig-2-apr-1-mobile-scaled.png\" alt=\"\" width=\"728\" height=\"1062\" \/><\/figure>\n<!-- \/wp:verse -->\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-859f692 elementor-widget elementor-widget-text-editor\" data-id=\"859f692\" 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>Figure adapted from Yau T, et al 2025.<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-0c956ad elementor-widget elementor-widget-text-editor\" data-id=\"0c956ad\" 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<h2>CheckMate 040 Cohort 4 (Phase 1\/2)<sup>2<\/sup><\/h2>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b639615 elementor-widget elementor-widget-text-editor\" data-id=\"b639615\" 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<ul>\n<li>Phase 1\/2, dose-escalation, open-label study in patients with advanced HCC<sup>2<\/sup><\/li>\n<li>Primary endpoints: Safety and tolerability using NCI CTCAE v4.0, ORR and DOR by investigator assessment<sup>a,2<\/sup><\/li>\n<li>Secondary endpoints: DCR, PFS, OS, TTP, TTR<sup>2<\/sup><\/li>\n<li>Other key endpoints: BOR and ORR based on BICR-assessed tumor response<sup>a<\/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-7e218e6b elementor-widget elementor-widget-text-editor\" data-id=\"7e218e6b\" 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-1211 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2026\/03\/1l-advanced-hcc-study-design-fig-1-mar-9.png\" alt=\"\" width=\"1482\" height=\"262\" \/><\/figure>\n<figure class=\"wp-block-image size-full img-fluid d-block d-md-none\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1212 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/checkmate_040_m-768x1186-mobile.png\" alt=\"\" width=\"728\" height=\"1062\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/checkmate_040_m-768x1186-mobile.png 728w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/checkmate_040_m-768x1186-mobile-206x300.png 206w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/checkmate_040_m-768x1186-mobile-702x1024.png 702w\" sizes=\"auto, (max-width: 728px) 100vw, 728px\" \/><\/figure>\n<p><!-- \/wp:verse --><\/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-b302e9a elementor-widget elementor-widget-text-editor\" data-id=\"b302e9a\" 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>The FDA indication is only for patients previously treated with sorafenib.<br \/>**Only Arm A has been approved by the FDA.<\/p>\n<p><sup>a<\/sup>Using RECIST v1.1.<\/p>\n<p>Figure adapted from Yau et al. 2020.<sup>2<\/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-ad843d2 elementor-widget elementor-widget-text-editor\" data-id=\"ad843d2\" 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; BID, twice a day; BOR, best overall response; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; HRQoL, health-related quality of life; IPI, ipilimumab; LRT, locoregional therapy; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NIVO, nivolumab; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PO, oral administration; QD, once a day; QxW, every x weeks; TTP, time to progression; TTD, time to deterioration; TTR, time to response.<\/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-b63a1bc elementor-widget elementor-widget-text-editor\" data-id=\"b63a1bc\" 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>1. Yau T, et al. <em>The Lancet<\/em> 2025;405:1851-1864.<\/p>\n<p>2. Yau T, et al. <em>JAMA Oncol <\/em>2020;6:e204564.<\/p>\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>CheckMate 9DW (Phase 3)1 Phase 3, randomised, open-label study investigating nivolumab plus ipilimumab in a first line setting in patients with unresectable HCC without previous systemic therapy1 Primary endpoints: OS1 Secondary endpoints: ORR, DOR, TTD1 Exploratory endpoints: safety, PFS, TTR per BICR, ORR and PFS on next-line therapy, HRQoL, influence of PD-L1 on overall survival1 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":213,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"page-template3.php","meta":{"footnotes":""},"class_list":["post-221","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/221","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=221"}],"version-history":[{"count":90,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/221\/revisions"}],"predecessor-version":[{"id":1831,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/221\/revisions\/1831"}],"up":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/213"}],"wp:attachment":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/media?parent=221"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}