CheckMate 459
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
- NCT02576509 ↗
- Completed
- Bristol-Myers Squibb
- Deep
We haven't built an HCP commentary report on CheckMate 459 (nivolumab in first-line advanced hepatocellular carcinoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Questions raised in the commentary
Automated from the 24 newest of 29 indexed sources (Nov 2018 – Oct 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.
- Whether biomarkers can identify patients likely to benefit from nivolumab
- Whether viral versus non-viral etiology modifies checkpoint inhibitor benefit
- Whether Wnt/β-catenin status can guide treatment selection
Also discussed: single-agent versus combination immunotherapy, withdrawal of nivolumab's HCC indication.
Indexed commentary on CheckMate 459 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 17 | |
| Podcasts | 7 | |
| YouTube | 5 |
The trial
ClinicalTrials.gov- 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)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Nivolumab; Sorafenib
- Arms
- Nivolumab · Experimental
- Sorafenib · Active comparator
- Enrollment
- 743
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Bristol-Myers Squibb with Ono Pharmaceutical Co., Ltd.
- Start
- Dec 7, 2015
- Primary completion
- May 30, 2019
- Results posted
- Yes
- Registry record
- NCT02576509 · updated Feb 17, 2025
Publications
linked from the registry- 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. PubMed 42762856
- 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. PubMed 39560477
- 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. PubMed 36852452
- 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. PubMed 36111952
- 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. PubMed 35101942
- 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. PubMed 34914889