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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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
Show all 9Show fewer
  • 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

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Japan2 sites, 2 recruiting

  • National Cancer Center Hospital East

    Chiba

    Recruiting

  • Mebix. Inc

    Minato-ku, Tokyo, 1050001

    Minoru Tonogai, Site 0001

    Recruiting

Other trials in Japan

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.

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 groups in NCT07679061
Study groupRoleWhat they receive
Nivolumab plus ipilimumab cohortParticipants 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.

  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.

    Measured: Up to 2 years

  2. 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

  3. 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

  4. Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae)

    Measured: Up to 2 years

  5. Treatment prescribed to participants for immune-mediated liver injury (IMLI)

    Measured: Up to 2 years

  6. 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

  7. 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

  8. 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

  9. Duration of nivolumab plus ipilimumab combination therapy

    Time from first dose of nivolumab plus ipilimumab to treatment discontinuation.

    Measured: Up to 2 years

  10. 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

  11. Number of participants who discontinue treatment

    Number of participants who discontinue nivolumab plus ipilimumab.

    Measured: Up to 2 years

  12. 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)

  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).

    Measured: Up to 2 years

  2. 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

  3. Time to resolution of immune-mediated adverse events (IMAEs)

    Time from onset of immune-mediated adverse events to resolution.

    Measured: Up to 2 years

  4. Number of participants with immune-mediated adverse events (IMAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)

    Measured: Up to 2 years

  5. Treatment prescribed to participants for immune-mediated adverse events (IMAEs)

    Measured: Up to 2 years

  6. Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation

    Measured: Up to 2 years

  7. 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

  8. 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

  9. Time to resolution of treatment-related adverse events (TRAEs)

    Time from onset of immune-mediated adverse events to resolution.

    Measured: Up to 2 years

  10. Number of participants with treatment-related adverse events (TRAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)

    Measured: Up to 2 years

  11. Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation

    Measured: Up to 2 years

  12. 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

  13. Overall survival (OS

    Time from first dose of nivolumab plus ipilimumab to death from any cause.

    Measured: Up to 2 years

  14. 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

  15. 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

  16. 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

  17. 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

  18. Change from baseline in albumin-bilirubin (ALBI) and modified ALBI (mALBI) grades based on laboratory values.

    Measured: Up to 2 years

  19. 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

  20. 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.

  1. First posted1 Jul 2026
  2. Study start5 Mar 2026
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

An observational study of Unresectable Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with grade ≥3 immune-mediated liver injury (IMLI) (time frame: Up to 2 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07679061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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