Phase 3
Completed N=743
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov NCT02576509 ↗Enrolled (actual)
743
Serious AEs
59.2%
Results posted
Jun 2020
Primary outcomePrimary: Overall Survival (OS) — 16.39; 14.69 Months — p=0.0752
◆ Published Evidence
Highly cited
1,087citations · ~272 / year
Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial.
Summary
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.
Linked Publications (5)
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Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial.
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Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy.
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Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis.
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Interventional Oncology Meets Immuno-oncology: Combination Therapies for Hepatocellular Carcinoma.
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Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
16.39; 14.69 | 0.0752 |
| SECONDARY Objective Response Rate (ORR) Per BICR RECIST 1.1 |
15.4; 7.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.68; 3.75 | — |
| SECONDARY Efficacy Based on PD-L1 Expression - OS and PFS |
16.07; 8.62; 3.84; 3.58; 16.72; 15.24 | — |
| SECONDARY Efficacy Based on PD-L1 Expression - ORR |
28.2; 9.4; 12.2; 6.7; 20.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
- Child-Pugh Class A
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant
- Active, known, or suspected autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02576509) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.