{"entity":{"id":"himalaya","kind":"trial","name":"HIMALAYA","aka":[],"tldr":"A single dose of a CTLA-4 antibody added to PD-L1 blockade doubled five-year survival in liver cancer without needing an anti-VEGF drug.","summary":"HIMALAYA, trial NCT03298451 sponsored by AstraZeneca and reported in 2022, showed that a single priming dose of the CTLA-4 antibody tremelimumab added to durvalumab, the STRIDE regimen, improves survival in first-line unresectable hepatocellular carcinoma compared with sorafenib without needing an anti-VEGF drug. It randomised 1,171 patients, met its primary overall survival endpoint, and its five-year update, the longest follow-up of any phase 3 in liver cancer, showed roughly twice as many long-term survivors with STRIDE, while durvalumab alone was non-inferior to sorafenib. OnCo links it to PD-L1 and CTLA-4 as targets, durvalumab, tremelimumab and Ghassan K. Abou-Alfa, and with no bleeding risk it is usable in patients with varices. The STRIDE plus TACE strategy is being tested in EMERALD-3, and how to choose between STRIDE and atezolizumab plus bevacizumab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03298451","url":"https://clinicaltrials.gov/study/NCT03298451"},{"label":"HIMALAYA 5-year OS (PubMed)","url":"https://pubmed.ncbi.nlm.nih.gov/40222621/"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1","ctla4"],"drugs":["durvalumab","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ghassan-abou-alfa"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03298451","phase":"3","setting":"First-line unresectable HCC: STRIDE (single priming dose tremelimumab + durvalumab) vs sorafenib","sponsor":"AstraZeneca","result":"OS HR 0.78; 5-year OS 19.6% vs 9.4%.","started":"2017-10-11","startedType":"actual","yearReported":2022,"enrolled":1171,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"STRIDE","n":393,"value":16.4},{"name":"Sorafenib","n":389,"value":13.8}],"hr":0.78,"ci":[0.66,0.92],"source":"https://doi.org/10.1056/EVIDoa2100070"},{"endpoint":"5-year overall survival","unit":"%","arms":[{"name":"STRIDE","value":19.6},{"name":"Sorafenib","value":9.4}],"hr":0.76,"source":"https://pubmed.ncbi.nlm.nih.gov/40222621/"}],"replication":"Five-year follow-up of the same trial; the STRIDE + TACE strategy is being tested in EMERALD-3."},"route":"/trials/himalaya/","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/"},{"id":"hcc-intermediate","kind":"cancer","name":"Intermediate hepatocellular carcinoma (BCLC B)","route":"/cancers/hcc-intermediate/"}],"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":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"tremelimumab","kind":"drug","name":"Tremelimumab","route":"/drugs/tremelimumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"person":[{"id":"ghassan-abou-alfa","kind":"person","name":"Ghassan K. Abou-Alfa","route":"/people/ghassan-abou-alfa/"}],"pairing":[{"id":"io-varices-caution","kind":"pairing","name":"Caution: bevacizumab-based regimens with untreated varices","route":"/pairings/io-varices-caution/"}],"paper":[{"id":"paper-himalaya-nejm-evidence-2022","kind":"paper","name":"HIMALAYA: tremelimumab plus durvalumab in unresectable hepatocellular carcinoma","route":"/key-papers/paper-himalaya-nejm-evidence-2022/"}]}}