A Phase 3 Study of ONO-4538/BMS-936558 (CA209459/ONO-4538-35)

A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma (CA209459/ONO-4538-35)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223055

Enrollment

726

Registered

2015-12-24

Start date

2015-11-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Advanced Hepatocellular Carcinoma

Interventions

investigational material(s) Generic name etc : Nivolumab(ONO-4538/BMS-936558) INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies 2. Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan 3. Child-Pugh Class A 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion criteria

Exclusion criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC 2. Prior liver transplant 3. Active, known, or suspected autoimmune disease

Design outcomes

Primary

Measure	Time frame
efficacy 1. Overall Survival (OS)	—

Secondary

Measure	Time frame
efficacy 1. Overall Response Rate (ORR) 2. Progression-Free Survival (PFS) 3. PD-L1 expression	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026