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
This trial does not accept healthy volunteersQualifiers
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 population
Adults in Japan with Child-Pugh class A unresectable hepatocellular carcinoma initiating first-line nivolumab plus ipilimumab in routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Nivolumab plus ipilimumab
Combination productAccording to product label
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Nivolumab plus ipilimumab cohort1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with grade ≥3 immune-mediated liver injury (IMLI)
Number of participants who experience grade 3-5 immune-mediated liver injury (IMLI), defined as treatment-related hepatic adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Up to 2 years2
Time to onset of immune-mediated liver injury (IMLI)
Time from first dose of nivolumab plus ipilimumab to first occurrence of immune-mediated liver injury (any grade).
Time frame
Up to 2 years3
Time to resolution of immune-mediated liver injury (IMLI)
Time from onset of immune-mediated liver injury to resolution, defined as recovery, recovery with sequelae, or improvement per clinician assessment.
Time frame
Up to 2 years4
Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae)
Time frame
Up to 2 yearsSecondary outcomes
1
Number of participants with immune-mediated adverse events (IMAEs)
Number of participants experiencing IMAEs, defined as treatment-related adverse events with immune-mediated etiology, categorized by CTCAE v5.0 grade (1-5).
Time frame
Up to 2 years2
Time to onset of immune-mediated adverse events (IMAEs)
Time from treatment initiation to onset of immune-mediated adverse events.
Time frame
Up to 2 years3
Time to resolution of immune-mediated adverse events (IMAEs)
Time from onset of immune-mediated adverse events to resolution.
Time frame
Up to 2 years4
Number of participants with immune-mediated adverse events (IMAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bristol-Myers Squibb
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov