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 - CheckMate 459

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002740-13-FR

Enrollment

908

Registered

2015-12-11

Start date

2018-03-21

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma MedDRA version: 18.1 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Nivolumab Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-936558-01 Other d

Eligibility

Sex/Gender

All

Inclusion 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 545 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 363

Exclusion criteria

Exclusion criteria: -Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC -Prior liver transplant -Active, known, or suspected autoimmune disease

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.;Secondary Objective: -Overall Response Rate (ORR) -Progression-Free Survival (PFS) -PD-L1 expression;Primary end point(s): -Time To Progression (TTP) -Overall Survival (OS);Timepoint(s) of evaluation of this end point: -Time To Progression (TTP):Approximately 18 months -Overall Survival (OS): Approximately 33 months	—

Measure

Time frame

Main Objective: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.;Secondary Objective: -Overall Response Rate (ORR) -Progression-Free Survival (PFS) -PD-L1 expression;Primary end point(s): -Time To Progression (TTP) -Overall Survival (OS);Timepoint(s) of evaluation of this end point: -Time To Progression (TTP):Approximately 18 months -Overall Survival (OS): Approximately 33 months

—

Secondary

Measure	Time frame
Secondary end point(s): -Overall Response Rate (ORR) -Progression-Free Survival (PFS) -PD-L1 expression;Timepoint(s) of evaluation of this end point: -Overall Response Rate (ORR):Approximately 33 months -Progression-Free Survival (PFS):Approximately 33 months -PD-L1 expression:Approximately 33 months	—

Countries

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Poland, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026