First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
This study looks at how a combination of two medicines, nivolumab and ipilimumab, is used to treat people with advanced liver cancer that cannot be removed by surgery. The study will follow adults receiving this treatment in routine medical care in Japan to understand how safe it is, how well it works, and how it is used in standard clinical practice.
Eligibility criteria
Qualifiers
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
Disqualifiers
Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma
Prior liver transplant
ECOG performance status ≥ 3
Uncontrolled comorbidities despite treatment
Trial design
Treatments tested in this trial
- Nivolumab plus ipilimumab
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Bristol-Myers Squibb
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov