{"entity":{"id":"nct03755791","kind":"trial","name":"Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Rece","aka":["COSMIC-312"],"tldr":"A phase 3 trial of Cabozantinib, Sorafenib, Atezolizumab in hepatocellular carcinoma, run by Exelixis, active and no longer recruiting.","summary":"Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy is a phase 3 interventional study registered as NCT03755791 by Exelixis, with 837 participants enrolled, started 2018-06-10 and due to reach its primary completion in 2021-11-30. Interventions recorded: Cabozantinib, Cabozantinib, Sorafenib, Atezolizumab. Conditions listed: Hepatocellular Carcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03755791","url":"https://clinicaltrials.gov/study/NCT03755791"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib","sorafenib","atezolizumab"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03755791","phase":"3","setting":"A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy","sponsor":"Exelixis","started":"2018-06-10","startedType":"actual","yearReported":2025,"enrolled":837,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population","primary":true,"unit":"months","arms":[{"name":"Experimental Arm: Cabozantinib + Atezolizumab","n":250,"value":6.8,"note":"99% CI 5.55 to 8.34; Figures from the ClinicalTrials.gov results section (first posted 2025-12-11), not from a publication"},{"name":"Control Arm: Sorafenib","n":122,"value":4.21,"note":"99% CI 2.79 to 7.03"}],"hr":0.63,"p":"0.0012","source":"https://clinicaltrials.gov/study/NCT03755791?tab=results"},{"endpoint":"Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population","primary":true,"unit":"months","arms":[{"name":"Experimental Arm: Cabozantinib + Atezolizumab","n":432,"value":16.46,"note":"96% CI 14.46 to 18.56; Figures from the ClinicalTrials.gov results section (first posted 2025-12-11), not from a publication"},{"name":"Control Arm: Sorafenib","n":217,"value":15.51,"note":"96% CI 12.19 to 19.98"}],"hr":0.99,"p":"0.9056","source":"https://clinicaltrials.gov/study/NCT03755791?tab=results"}]},"route":"/trials/nct03755791/","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":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"cabozantinib","kind":"drug","name":"Cabozantinib","route":"/drugs/cabozantinib/"},{"id":"sorafenib","kind":"drug","name":"Sorafenib","route":"/drugs/sorafenib/"}],"company":[{"id":"exelixis","kind":"company","name":"Exelixis","route":"/companies/exelixis/"}],"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/"}]}}