{"preliminary_commentary":{"by_channel":{"x_thread":20,"podcast":7,"youtube":5},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02576509\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":{"generated_at":"2026-11-02T19:27:04.219Z","note":"Automated from the 24 newest of 32 indexed sources (Nov 2018 – Oct 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.","passages_read":24,"text":"- Whether biomarkers can identify patients likely to benefit from nivolumab\n- Whether viral versus non-viral etiology modifies checkpoint inhibitor benefit\n- Whether Wnt/β-catenin status can guide treatment selection\n\nAlso discussed: single-agent versus combination immunotherapy, withdrawal of nivolumab's HCC indication."},"drugs_tested":[["nivolumab"]],"indication":"first-line advanced hepatocellular carcinoma","name":"CheckMate 459","nct_id":"NCT02576509","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=checkmate-459-nct02576509. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Nivolumab specified dose on specified days","label":"Nivolumab","type":"EXPERIMENTAL"},{"description":"Sorafenib specified dose on specified days","label":"Sorafenib","type":"ACTIVE_COMPARATOR"}],"collaborators":["Ono Pharmaceutical Co., Ltd."],"completion_date":{"date":"2024-02-07","type":"ACTUAL"},"conditions":["Hepatocellular Carcinoma"],"enrollment":{"count":743,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nivolumab","otherNames":[],"type":"DRUG"},{"name":"Sorafenib","otherNames":[],"type":"DRUG"}],"last_update":"2025-02-17","lead_sponsor":"Bristol-Myers Squibb","official_title":"A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-05-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months)"}],"references":[{"citation":"Neely J, Yao J, Kudo M, Finn RS, Sangro B, Melero I, El-Khoueiry AB, Yau T, Harding JJ, Rosmorduc O, Tschaika M, Novosiadly R, Cruz A, Kelley RK. Biomarkers associated with efficacy of first-line nivolumab vs. sorafenib in advanced hepatocellular carcinoma: results from the CheckMate 459 phase III trial. JHEP Rep. 2026 Sep 19:102038. doi: 10.1016/j.jhepr.2026.102038. Online ahead of print.","pmid":"42762856","type":"DERIVED"},{"citation":"Bitar R, Salem R, Finn R, Greten TF, Goldberg SN, Chapiro J. Interventional Oncology Meets Immuno-oncology: Combination Therapies for Hepatocellular Carcinoma. Radiology. 2024 Nov;313(2):e232875. doi: 10.1148/radiol.232875.","pmid":"39560477","type":"DERIVED"},{"citation":"Zhou X, Cao J, Topatana W, Xie T, Chen T, Hu J, Li S, Juengpanic S, Lu Z, Zhang B, Wang K, Feng X, Shen J, Chen M. Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis. Immunotherapy. 2023 Apr;15(5):353-365. doi: 10.2217/imt-2022-0168. Epub 2023 Feb 27.","pmid":"36852452","type":"DERIVED"},{"citation":"Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.","pmid":"36111952","type":"DERIVED"},{"citation":"Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.","pmid":"35101942","type":"DERIVED"},{"citation":"Yau T, Park JW, Finn RS, Cheng AL, Mathurin P, Edeline J, Kudo M, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Sieghart W, Assenat E, Zaucha R, Furuse J, Abou-Alfa GK, El-Khoueiry AB, Melero I, Begic D, Chen G, Neely J, Wisniewski T, Tschaika M, Sangro B. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):77-90. doi: 10.1016/S1470-2045(21)00604-5. Epub 2021 Dec 13.","pmid":"34914889","type":"DERIVED"}],"start_date":{"date":"2015-12-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma","url":"https://clinicaltrials.gov/study/NCT02576509"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/checkmate-459-nct02576509"}