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

25. juni 2026 opdateret af: Bristol-Myers Squibb

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: First line of the email MUST contain NCT # and Site #.

Undersøgelse Kontakt Backup

  • Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Telefonnummer: 855-907-3286
  • E-mail: Clinical.Trials@bms.com

Studiesteder

  • Japan
      • Chiba, Japan
        • Rekruttering
        • National Cancer Center Hospital East
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1050001
        • Rekruttering
        • Mebix. Inc
        • Kontakt:
          • Minoru Tonogai, Site 0001

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Nivolumab plus ipilimumab cohort
Participants with unresectable hepatocellular carcinoma receiving nivolumab plus ipilimumab as first-line systemic therapy in routine clinical practice in Japan.
Kombinationsprodukt: Nivolumab plus ipilimumab
According to product label

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with grade ≥3 immune-mediated liver injury (IMLI)
Tidsramme: 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.
Up to 2 years
Time to onset of immune-mediated liver injury (IMLI)
Tidsramme: Up to 2 years
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)
Tidsramme: 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.
Up to 2 years
Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae)
Tidsramme: Up to 2 years
Up to 2 years
Treatment prescribed to participants for immune-mediated liver injury (IMLI)
Tidsramme: Up to 2 years
Up to 2 years
Objective response rate (ORR)
Tidsramme: 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.
Up to 2 years
Best overall response (BOR)
Tidsramme: 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.
Up to 2 years
Disease control rate (DCR
Tidsramme: 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.
Up to 2 years
Duration of nivolumab plus ipilimumab combination therapy
Tidsramme: Up to 2 years
Time from first dose of nivolumab plus ipilimumab to treatment discontinuation.
Up to 2 years
Number of nivolumab plus ipilimumab treatment cycles per participant
Tidsramme: Up to 2 years
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
Tidsramme: Up to 2 years
Number of participants who discontinue nivolumab plus ipilimumab.
Up to 2 years
Reasons for treatment discontinuation
Tidsramme: Up to 2 years
Distribution of reasons, including disease progression, adverse events death, participant request, transfer, or other reasons as assessed by treating clinician.
Up to 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with immune-mediated adverse events (IMAEs)
Tidsramme: Up to 2 years
Number of participants experiencing IMAEs, defined as treatment-related adverse events with immune-mediated etiology, categorized by CTCAE v5.0 grade (1-5).
Up to 2 years
Time to onset of immune-mediated adverse events (IMAEs)
Tidsramme: Up to 2 years
Time from treatment initiation to onset of immune-mediated adverse events.
Up to 2 years
Time to resolution of immune-mediated adverse events (IMAEs)
Tidsramme: Up to 2 years
Time from onset of immune-mediated adverse events to resolution.
Up to 2 years
Number of participants with immune-mediated adverse events (IMAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)
Tidsramme: Up to 2 years
Up to 2 years
Treatment prescribed to participants for immune-mediated adverse events (IMAEs)
Tidsramme: Up to 2 years
Up to 2 years
Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation
Tidsramme: Up to 2 years
Up to 2 years
Number of participants with treatment-related adverse events (TRAEs)
Tidsramme: Up to 2 years
Number of participants experiencing treatment-related adverse events categorized by preferred term and CTCAE v5.0 grade.
Up to 2 years
Time to onset of treatment-related adverse events (TRAEs)
Tidsramme: Up to 2 years
Time from treatment initiation to onset of immune-mediated adverse events.
Up to 2 years
Time to resolution of treatment-related adverse events (TRAEs)
Tidsramme: Up to 2 years
Time from onset of immune-mediated adverse events to resolution.
Up to 2 years
Number of participants with treatment-related adverse events (TRAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)
Tidsramme: Up to 2 years
Up to 2 years
Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation
Tidsramme: Up to 2 years
Up to 2 years
Duration of response (DOR)
Tidsramme: Up to 2 years
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
Up to 2 years
Overall survival (OS
Tidsramme: Up to 2 years
Time from first dose of nivolumab plus ipilimumab to death from any cause.
Up to 2 years
Progression-free survival (PFS)
Tidsramme: Up to 2 years
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.
Up to 2 years
Second progression-free survival (PFS2)
Tidsramme: Up to 2 years
Time from first dose of nivolumab plus ipilimumab to progression after second-line therapy or death from any cause, whichever occurs first.
Up to 2 years
Depth of response (DpR)
Tidsramme: Up to 2 years
Maximum percentage reduction from baseline in the sum of diameters of target lesions among participants with measurable disease.
Up to 2 years
Change from baseline in Child-Pugh score
Tidsramme: Up to 2 years
Change from baseline in Child-Pugh score (range 5-15), including classification into Class A, B, or C.
Up to 2 years
Change from baseline in albumin-bilirubin (ALBI) and modified ALBI (mALBI) grades based on laboratory values.
Tidsramme: Up to 2 years
Up to 2 years
Number of participants receiving subsequent therapy
Tidsramme: Up to 2 years
Number of participants who receive any subsequent anticancer therapy after discontinuation of nivolumab plus ipilimumab
Up to 2 years
Type of subsequent therapy received
Tidsramme: Up to 2 years
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.
Up to 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Samarbejdspartnere

Ono Pharmaceutical Co., Ltd.

Efterforskere

  • Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. marts 2026

Primær færdiggørelse (Anslået)

29. februar 2028

Studieafslutning (Anslået)

29. februar 2028

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-1554

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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