Unresectable Hepatocellular CarcinomaNCT07679061
First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)
An observational study of Unresectable Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 2 sites in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Nivolumab plus ipilimumab
- How many people
- 200 participants
- Where
- 2 sitesJapan
- Study dates
- 5 Mar 2026to 29 Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults in Japan with Child-Pugh class A unresectable hepatocellular carcinoma initiating first-line nivolumab plus ipilimumab in routine clinical practice.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital East
Chiba
- Recruiting
Mebix. Inc
Minato-ku, Tokyo, 1050001
Minoru Tonogai, Site 0001
About this study
Official title: Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)
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.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Nivolumab plus ipilimumab
- Keywords
- Hepatocellular carcinoma; HCC; nivolumab; ipilimumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab plus ipilimumabCombination product
According to product label
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab plus ipilimumab cohort | Participants with unresectable hepatocellular carcinoma receiving nivolumab plus ipilimumab as first-line systemic therapy in routine clinical practice in Japan. Receives: Combination Product: Nivolumab plus ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
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).
Measured: Up to 2 years
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.
Measured: Up to 2 years
Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae)
Measured: Up to 2 years
Treatment prescribed to participants for immune-mediated liver injury (IMLI)
Measured: Up to 2 years
Objective response rate (ORR)
Number of participants with complete response (CR) or partial response (PR) as best overall response among participants with baseline target lesions, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to 2 years
Best overall response (BOR)
Distribution of best overall response categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) among participants with baseline target lesions per RECIST v1.1.
Measured: Up to 2 years
Disease control rate (DCR
Number of participants with complete response (CR), partial response (PR), or stable disease (SD) as best overall response among participants with baseline target lesions per RECIST v1.1.
Measured: Up to 2 years
Duration of nivolumab plus ipilimumab combination therapy
Time from first dose of nivolumab plus ipilimumab to treatment discontinuation.
Measured: Up to 2 years
Number of nivolumab plus ipilimumab treatment cycles per participant
Total number of administered cycles of nivolumab plus ipilimumab given every 3 weeks, summarized per participant.
Measured: Up to 2 years
Number of participants who discontinue treatment
Number of participants who discontinue nivolumab plus ipilimumab.
Measured: Up to 2 years
Reasons for treatment discontinuation
Distribution of reasons, including disease progression, adverse events death, participant request, transfer, or other reasons as assessed by treating clinician.
Measured: Up to 2 years
Secondary outcomes (20)
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).
Measured: Up to 2 years
Time to onset of immune-mediated adverse events (IMAEs)
Time from treatment initiation to onset of immune-mediated adverse events.
Measured: Up to 2 years
Time to resolution of immune-mediated adverse events (IMAEs)
Time from onset of immune-mediated adverse events to resolution.
Measured: Up to 2 years
Number of participants with immune-mediated adverse events (IMAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)
Measured: Up to 2 years
Treatment prescribed to participants for immune-mediated adverse events (IMAEs)
Measured: Up to 2 years
Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation
Measured: Up to 2 years
Number of participants with treatment-related adverse events (TRAEs)
Number of participants experiencing treatment-related adverse events categorized by preferred term and CTCAE v5.0 grade.
Measured: Up to 2 years
Time to onset of treatment-related adverse events (TRAEs)
Time from treatment initiation to onset of immune-mediated adverse events.
Measured: Up to 2 years
Time to resolution of treatment-related adverse events (TRAEs)
Time from onset of immune-mediated adverse events to resolution.
Measured: Up to 2 years
Number of participants with treatment-related adverse events (TRAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)
Measured: Up to 2 years
Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation
Measured: Up to 2 years
Duration of response (DOR)
Time from first documented complete response (CR) or partial response (PR) to disease progression per RECIST v1.1 or death from any cause, whichever occurs first
Measured: Up to 2 years
Overall survival (OS
Time from first dose of nivolumab plus ipilimumab to death from any cause.
Measured: Up to 2 years
Progression-free survival (PFS)
Time from first dose of nivolumab plus ipilimumab to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to 2 years
Second progression-free survival (PFS2)
Time from first dose of nivolumab plus ipilimumab to progression after second-line therapy or death from any cause, whichever occurs first.
Measured: Up to 2 years
Depth of response (DpR)
Maximum percentage reduction from baseline in the sum of diameters of target lesions among participants with measurable disease.
Measured: Up to 2 years
Change from baseline in Child-Pugh score
Change from baseline in Child-Pugh score (range 5-15), including classification into Class A, B, or C.
Measured: Up to 2 years
Change from baseline in albumin-bilirubin (ALBI) and modified ALBI (mALBI) grades based on laboratory values.
Measured: Up to 2 years
Number of participants receiving subsequent therapy
Number of participants who receive any subsequent anticancer therapy after discontinuation of nivolumab plus ipilimumab
Measured: Up to 2 years
Type of subsequent therapy received
Distribution of subsequent therapies received after discontinuation of nivolumab plus ipilimumab, including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), surgery, radiation therapy, and systemic therapies.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start5 Mar 2026
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679061
- Sponsor's protocol ID
- CA209-1554
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No