{"entity":{"id":"checkmate-9dw","kind":"trial","name":"CheckMate 9DW","aka":[],"tldr":"Dual immune checkpoint blockade gave the longest median survival yet seen in a first-line liver cancer trial.","summary":"CheckMate 9DW, trial NCT04039607 sponsored by Bristol Myers Squibb and reported in 2024, showed that dual checkpoint blockade with nivolumab plus ipilimumab gives the longest median survival yet seen in a first-line liver cancer trial. It randomised 668 patients with unresectable hepatocellular carcinoma to the combination or to lenvatinib or sorafenib, met its primary overall survival endpoint, and produced a much higher response rate with far more durable responses, leading to FDA approval in April 2025, at the cost of more immune-related toxicity than single-agent regimens. OnCo links it to PD-1 and CTLA-4 as targets and to nivolumab and ipilimumab. Whether the extra toxicity is worth it for all patients, or whether a biomarker could pick those who need the CTLA-4 component, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04039607","url":"https://clinicaltrials.gov/study/NCT04039607"},{"label":"Lancet 2025","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00403-9/fulltext"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04039607","phase":"3","setting":"First-line unresectable HCC: nivolumab + ipilimumab vs lenvatinib or sorafenib","sponsor":"BMS","result":"OS 23.7 vs 20.6 months, HR 0.79; ORR 36% vs 13%.","started":"2019-09-30","startedType":"actual","yearReported":2024,"enrolled":732,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","n":335,"value":23.7},{"name":"Lenvatinib or sorafenib","n":333,"value":20.6}],"hr":0.79,"ci":[0.65,0.96],"p":"0.018","source":"https://doi.org/10.1016/S0140-6736(25)00403-9"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":36},{"name":"Lenvatinib or sorafenib","value":13}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(25)00403-9"}]},"route":"/trials/checkmate-9dw/","neighbours":{"cancer":[{"id":"hcc-advanced","kind":"cancer","name":"Advanced hepatocellular carcinoma (BCLC C)","route":"/cancers/hcc-advanced/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"idea":[{"id":"idea-hcc-io-before-transplant","kind":"idea","name":"Immunotherapy downstaging to transplant with a safe washout","route":"/ideas/idea-hcc-io-before-transplant/"}]}}