Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

No longer recruiting (closed or complete)Last updated: 27 February 2025

Checkmate 459: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

Checkmate 459

Clinical summary

Summary

Eligible participants will receive either nivolumab or sorafenib.

Conditions

This trial is treating people with liver cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

No longer recruiting (closed or complete) hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information