A Phase 1/2 Study of ONO-4538/BMS-936558(ONO-4538-20/CA209040)

A Phase 1/2, Dose-escalation, Open-label Study of Nivolumab or Nivolumab in Combination with Other Agents in Advanced Hepatocellular Carcinoma Subjects with or without Chronic Viral Hepatitis(ONO-4538-20/CA209040)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222889

Enrollment

620

Registered

2015-06-24

Start date

2015-07-01

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

Hepatocellular Carcinoma

Interventions

investigational material(s) Generic name etc : Nivolumab(ONO-4538/BMS-936558) , Ipilimumab, Cabozantinib INN of investigational material : Nivolumab, Ipilimumab, Cabozantinib Therapeutic category code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological confirmation of advanced hepatocellular carcinoma 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 3. Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less

Exclusion criteria

Exclusion criteria: 1. History of autoimmune disease 2. Any prior or current clinically significant ascites 3. Any history of hepatic encephalopathy

Design outcomes

Primary

Measure	Time frame
safety efficacy Safety, Response Rate	—

Secondary

Measure	Time frame
efficacy Time to progression(TTP), Progression free survival(PFS)	—

Countries

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

Outcome results

None listed

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