{"id":242,"date":"2021-06-30T15:15:33","date_gmt":"2021-06-30T15:15:33","guid":{"rendered":"https:\/\/mims.parabolasolution.com\/?page_id=242"},"modified":"2026-04-01T15:53:20","modified_gmt":"2026-04-01T07:53:20","slug":"study-design","status":"publish","type":"page","link":"https:\/\/bms.mimsit.net\/dosing\/1l-msi-h-d-mmr-metastatic-recurrent-crc\/study-design\/","title":{"rendered":"Study designs"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"242\" class=\"elementor elementor-242\" 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-525f1608 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"525f1608\" 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-447e0f92\" data-id=\"447e0f92\" 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-789d69b elementor-widget elementor-widget-text-editor\" data-id=\"789d69b\" 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 8HW (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-7c779ea elementor-widget elementor-widget-text-editor\" data-id=\"7c779ea\" 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 \t<li>Phase 3 randomised, multicentre, open-label study in patients with unresectable or metastatic CRC<sup>a,1<\/sup><\/li>\n \t<li>Primary endpoints: PFS by BICR (NIVO + IPI vs chemo in 1L; NIVO + IPI vs NIVO across all lines)<sup>1<\/sup><\/li>\n \t<li>Secondary endpoints: PFS by BICR, ORR by BICR (NIVO + IPI vs NIVO in 1L for both endpoints)<sup>1<\/sup><\/li>\n \t<li>Other key endpoints: Safety<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-e75975f elementor-widget elementor-widget-text-editor\" data-id=\"e75975f\" 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-1221 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2026\/04\/1l-msi-h-d-mmr-metastatic-recurrent-crc-study-design-fig-1-apr-1-1.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-1222 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2026\/04\/1l-msi-h-d-mmr-metastatic-recurrent-crc-study-design-fig-1-apr-1-mobile-scaled.png\" alt=\"\" width=\"1783\" height=\"2979\" \/><\/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-86c8083 elementor-widget elementor-widget-text-editor\" data-id=\"86c8083\" 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>ClinicalTrials.gov. NTC04008030.<sup>1<\/sup><br>\n<sup>b<\/sup>Patients with &gt;2 prior lines are randomised only to the NIVO or NIVO + IPI arms.<sup>1<\/sup><br>\n<sup>c<\/sup>Patients can continue NIVO treatment upon early IPI discontinuation.<sup>1<\/sup><br>\n<sup>d<\/sup>Patients receiving investigator\u2019s choice of chemo are eligible to receive NIVO + IPI upon progression (crossover treatment).<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-9f8dcc4 elementor-widget elementor-widget-text-editor\" data-id=\"9f8dcc4\" 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 142 (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-c51e529 elementor-widget elementor-widget-text-editor\" data-id=\"c51e529\" 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><li>Phase 2 multi-cohort study in patients with recurrent\/metastatic CRC<sup>2<\/sup><\/li><li>Primary endpoint: ORR per investigator assessment (RECIST v1.1)<sup>a,2<\/sup><\/li><li>Secondary endpoint: ORR per BICR<sup>a,2<\/sup><\/li><li>Other key endpoints: DCR, DOR, PFS, OS, and safety<sup>a,2<\/sup><\/li><\/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-1b710aea elementor-widget elementor-widget-text-editor\" data-id=\"1b710aea\" 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-1221 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC.png\" alt=\"\" width=\"4443\" height=\"629\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC.png 4443w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-300x42.png 300w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-1024x145.png 1024w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-768x109.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-1536x217.png 1536w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-2048x290.png 2048w\" sizes=\"auto, (max-width: 4443px) 100vw, 4443px\" \/><\/figure><figure class=\"wp-block-image size-full img-fluid d-block d-md-none\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1222 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-mobile.png\" alt=\"\" width=\"1783\" height=\"2979\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-mobile.png 1783w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-mobile-180x300.png 180w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-mobile-613x1024.png 613w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-mobile-768x1283.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-mobile-919x1536.png 919w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study-design-CheckMate-142-CRC-mobile-1226x2048.png 1226w\" sizes=\"auto, (max-width: 1783px) 100vw, 1783px\" \/><\/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-b76ae41 elementor-widget elementor-widget-text-editor\" data-id=\"b76ae41\" 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>Tumor imaging assessments were performed every 6 weeks for 24 weeks and thereafter every 12 weeks until disease progression or discontinuation.<sup>2<\/sup><br \/>Figure adapted from Overman et al. 2018.<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-97ecb98 elementor-widget elementor-widget-text-editor\" data-id=\"97ecb98\" 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>1L, first line; BICR, blinded independent central review; BID, twice a day; BOR, best overall response; CRC, colorectal cancer; 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; MSI-H\/dMMR, microsatellite instability-high\/mismatch repair deficient; 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; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; TTD, time to deterioration; TTP, time to progression; 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-4acc879 elementor-widget elementor-widget-text-editor\" data-id=\"4acc879\" 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. Andr\u00e9 T, et al. <em>N Engl J Med<\/em> 2024;391:2014-2026.<\/p><p>2.\u00a0Overman MJ, et al. <em>J Clin Oncol <\/em>2018;36:773-779.<\/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 8HW (Phase 3)1 Phase 3 randomised, multicentre, open-label study in patients with unresectable or metastatic CRCa,1 Primary endpoints: PFS by BICR (NIVO + IPI vs chemo in 1L; NIVO + IPI vs NIVO across all lines)1 Secondary endpoints: PFS by BICR, ORR by BICR (NIVO + IPI vs NIVO in 1L for both endpoints)1 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":231,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"page-template3.php","meta":{"footnotes":""},"class_list":["post-242","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/242","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=242"}],"version-history":[{"count":47,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/242\/revisions"}],"predecessor-version":[{"id":1812,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/242\/revisions\/1812"}],"up":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/231"}],"wp:attachment":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/media?parent=242"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}