{"entity":{"id":"nct02519348","kind":"trial","name":"A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of Tremelimumab, Durvalumab, Bevacizumab in hepatocellular carcinoma, run by MedImmune LLC, active and no longer recruiting.","summary":"A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT02519348 by MedImmune LLC, with 433 participants enrolled, started 2015-10-19 and due to reach its primary completion in 2020-11-06. Interventions recorded: Tremelimumab, Durvalumab, Bevacizumab. Conditions listed: Hepatocellular Carcinoma. Results were posted on ClinicalTrials.gov in 2021; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02519348","url":"https://clinicaltrials.gov/study/NCT02519348"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["tremelimumab","durvalumab","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02519348","phase":"2","setting":"A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Subjects With Advanced Hepatocellular Carcinoma","sponsor":"MedImmune LLC","started":"2015-10-19","startedType":"actual","yearReported":2021,"enrolled":433,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Dose Limiting Toxicities (DLTs)","primary":true,"unit":"participants","arms":[{"name":"Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg","n":16,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2021-12-06), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT02519348?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg","n":40,"value":12.58,"note":"95% CI 6.87 to 20.99; Figures from the ClinicalTrials.gov results section (first posted 2021-12-06), not from a publication"},{"name":"Parts 2 and 3: Durvalumab 1500 mg","n":104,"value":12.91,"note":"95% CI 8.74 to 16.79"},{"name":"Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg","n":75,"value":17.05,"note":"95% CI 10.55 to 22.83"},{"name":"Parts 2 and 3: Tremelimumab 750 mg","n":69,"value":17.05,"note":"95% CI 11.33 to 20.24"},{"name":"Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg","n":84,"value":11.3,"note":"95% CI 8.38 to 14.95"},{"name":"Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg","n":47,"note":"Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis."},{"name":"China Cohort: Durvalumab 20 mg/kg","n":3,"value":30.69,"note":"95% CI 13.96 to NA"},{"name":"China Cohort: Tremelimumab 10 mg/kg","n":5,"value":3.52,"note":"95% CI 2.20 to 20.96"},{"name":"China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg","n":6,"value":6.28,"note":"95% CI 0.66 to 23.82"}],"source":"https://clinicaltrials.gov/study/NCT02519348?tab=results"}]},"route":"/trials/nct02519348/","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":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"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/"}]}}