A Phase 3 Study of ONO-4538/BMS-936558 (CA2099DX/ONO-4538-70)

ONO-4538-70:A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation. (CA2099DX/ONO-4538-70)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223808

Enrollment

100

Registered

2018-02-13

Start date

2018-04-18

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) INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants with a first diagnosis of HCC who have undergone a curative resection or ablation 2. Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC 3. Child-Pugh Score 5 or 6 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. Any evidence of tumor metastasis or co-existing malignant disease 3. Participants previously receiving any prior therapy for HCC, including loco-regional therapies 4. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation

Design outcomes

Primary

Measure	Time frame
efficacy 1. Recurrence-free Survival (RFS)	—

Secondary

Measure	Time frame
efficacy 1. Overall Survival (OS) 2. Time to recurrence (TTR)	—

Countries

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

Outcome results

None listed

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