Clinical Trials in Japan / NCT07679061
Recruiting
Observational
First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)
NCT07679061 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Unresectable Hepatocellular Carcinoma
Investigational drug(s) / intervention(s)
Nivolumab plus ipilimumab
Nivolumab plus ipilimumab: According to product label
Study 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.
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
- Number of participants with grade ≥3 immune-mediated liver injury (IMLI) — Up to 2 years
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 to onset of immune-mediated liver injury (IMLI) — Up to 2 years
Time from first dose of nivolumab plus ipilimumab to first occurrence of immune-mediated liver injury (any grade). - Time to resolution of immune-mediated liver injury (IMLI) — Up to 2 years
Time from onset of immune-mediated liver injury to resolution, defined as recovery, recovery with sequelae, or improvement per clinician assessment. - 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) — Up to 2 years
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. - Best overall response (BOR) — Up to 2 years
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. - Disease control rate (DCR — Up to 2 years
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. - Duration of nivolumab plus ipilimumab combination therapy — Up to 2 years
Time from first dose of nivolumab plus ipilimumab to treatment discontinuation. - Number of nivolumab plus ipilimumab treatment cycles per participant — Up to 2 years
Total number of administered cycles of nivolumab plus ipilimumab given every 3 weeks, summarized per participant. - Number of participants who discontinue treatment — Up to 2 years
Number of participants who discontinue nivolumab plus ipilimumab. - Reasons for treatment discontinuation — Up to 2 years
Distribution of reasons, including disease progression, adverse events death, participant request, transfer, or other reasons as assessed by treating clinician.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Mebix. Inc | Minato-ku | Tokyo | Recruiting |
| National Cancer Center Hospital East | Chiba | Japan | Recruiting |
More Bristol-Myers Squibb trials in Japan
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07679061 on ClinicalTrials.gov ↗ ← All trials in Japan