{"entity":{"id":"leap-002","kind":"trial","name":"LEAP-002","aka":[],"tldr":"LEAP-002 randomised 794 patients with untreated advanced liver cancer to lenvatinib with or without pembrolizumab. Adding the immunotherapy did not lengthen life beyond lenvatinib alone, partly because the control arm did unusually well, a reminder that not every immunotherapy plus anti-angiogenic pairing works.","summary":"LEAP-002, trial NCT03713593 sponsored by Merck and Eisai and reported in 2022, found that adding pembrolizumab to lenvatinib did not extend life to a statistically significant degree in first-line unresectable hepatocellular carcinoma, a reminder that not every immunotherapy plus anti-angiogenic pairing works. It randomised 794 patients, and overall survival missed the prespecified boundary while progression-free survival was also not significant, with the lenvatinib control arm performing unusually well. OnCo links it to hepatocellular carcinoma, lenvatinib and pembrolizumab. Whether the failure reflects a strong comparator, the choice of PD-1 rather than PD-L1 blockade, or simple chance is the open question the trial left.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03713593","url":"https://clinicaltrials.gov/study/NCT03713593"}],"tags":["failure","lesson:control-arm"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["lenvatinib","pembrolizumab"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03713593","phase":"3","setting":"First-line unresectable HCC: lenvatinib + pembrolizumab vs lenvatinib","sponsor":"Merck / Eisai","result":"OS HR 0.84, not significant.","started":"2018-12-31","startedType":"actual","yearReported":2022,"enrolled":794,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","n":395,"value":21.2},{"name":"Lenvatinib","n":399,"value":19}],"hr":0.84,"ci":[0.71,1],"source":"https://doi.org/10.1016/S1470-2045(23)00469-2"}]},"route":"/trials/leap-002/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"lenvatinib","kind":"drug","name":"Lenvatinib","route":"/drugs/lenvatinib/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"eisai","kind":"company","name":"Eisai","route":"/companies/eisai/"}]}}