First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)

NCT07679061 | Recruiting FDA Drug

• 1 other identifier: CA209-1554
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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 used in standard clinical practice.

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; HCC; nivolumab; ipilimumab

Outcome Measures

Primary Outcomes (12)

• 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.

  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).

  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.

  Up to 2 years

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

  Up to 2 years

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

  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.

  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.

  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.

  Up to 2 years

• Duration of nivolumab plus ipilimumab combination therapy

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

  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.

  Up to 2 years

• Number of participants who discontinue treatment

  Number of participants who discontinue nivolumab plus ipilimumab.

  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.

  Up to 2 years

Secondary Outcomes (20)

• Number of participants with immune-mediated adverse events (IMAEs)

  Up to 2 years

• Time to onset of immune-mediated adverse events (IMAEs)

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

Study Arms (1)

Nivolumab plus ipilimumab cohort

Participants with unresectable hepatocellular carcinoma receiving nivolumab plus ipilimumab as first-line systemic therapy in routine clinical practice in Japan.

Combination Product: Nivolumab plus ipilimumab

Interventions

Nivolumab plus ipilimumab COMBINATION_PRODUCT

According to product label

Nivolumab plus ipilimumab cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults in Japan with Child-Pugh class A unresectable hepatocellular carcinoma initiating first-line nivolumab plus ipilimumab in routine clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Mebix. Inc

Minato-ku, Tokyo, 1050001, Japan

RECRUITING

National Cancer Center Hospital East

Chiba, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)