Check Mate 9DW: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9DW

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination with Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants with Advanced Hepatocellular Carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225035

Enrollment

1084

Registered

2020-01-23

Start date

2020-01-31

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 : INN of investigational material : Nivolumab, Ipilimumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must have a diagnosis of HCC based on histological confirmation Participants must have an advanced HCC Participants must have at least one Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 measurable previously untreated lesion Participants must not have received prior systemic therapy for unresectable/advanced HCC Child-Pugh score 5 or 6 Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion criteria

Exclusion criteria: Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC Prior liver transplant Episodes of hepatic encephalopathy (>= Grade 2) within 12 months prior to randomization Active brain metastases or leptomeningeal metastases

Design outcomes

Primary

Measure	Time frame
efficacy, OS	—

Secondary

Measure	Time frame
efficacy, ORR, DOR, TTSD	—

Countries

Asia except Japan, Japan

Contacts

Public ContactJenny Zhang

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

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