First-Line Nivolumab plus Ipilimumab in unresectable hepatocellular carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with unresectable hepatocellular carcinoma who start the combination of nivolumab and ipilimumab in routine clinical practice in Japan. It aims to document safety and how well the regimen works outside of a controlled trial setting, including real-world usage patterns. Eligible participants have Child-Pugh class A liver function and have not had prior systemic therapy for uHCC, with some allowances for prior adjuvant therapy or prior lenvatinib with TACE eligibility. The analysis will reflect routine care, dosing decisions, and outcomes in a real-world context across participating centers. The lead sponsor is Bristol-Myers Squibb, with Ono Pharmaceutical as a collaborator, and sites include Mebix in Tokyo and National Cancer Center Hospital East in Chiba.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants aged ≥ 18 years at the time of consent
* Participants with unresectable hepatocellular carcinoma (uHCC), defined as disease not eligible for curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies
* Child-Pugh class A (total score 5-6)
* Participants who have not received prior systemic drug therapy for uHCC

  * Participants who relapsed more than 6 months after completion of postoperative adjuvant therapy are eligible
  * Participants who received lenvatinib in combination with transarterial chemoembolization (TACE) are eligible if the treating physician determined they were eligible for TACE; participants are excluded if TACE eligibility at the time of lenvatinib initiation is unclear
* Participants scheduled to initiate nivolumab plus ipilimumab combination therapy between March 1, 2026 and February 28, 2027

  * Nivolumab plus ipilimumab combination therapy is defined as nivolumab 80 mg and ipilimumab 3 mg/kg administered intravenously every 3 weeks for 4 cycles, followed by nivolumab monotherapy at 240 mg every 2 weeks or 480 mg every 4 weeks
* Participants who provide written informed consent prior to initiation of nivolumab plus ipilimumab therapy

Exclusion Criteria:

* Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma
* Prior liver transplant
* ECOG performance status ≥ 3
* Uncontrolled comorbidities despite treatment
* Other advanced cancers requiring systemic therapy
* Prior immuno-oncology treatment
* Participation in interventional clinical trials at enrollment
* Deemed unsuitable by investigator

Where it's running

• Mebix. Inc
  Minato-ku, Tokyo, Japan Recruiting
• National Cancer Center Hospital East
  Chiba, Japan Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.