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

25. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studieren Sie die Kontaktsicherung

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

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with grade ≥3 immune-mediated liver injury (IMLI)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to 2 years
Up to 2 years
Treatment prescribed to participants for immune-mediated liver injury (IMLI)
Zeitfenster: Up to 2 years
Up to 2 years
Objective response rate (ORR)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 2 years
Number of participants who discontinue nivolumab plus ipilimumab.
Up to 2 years
Reasons for treatment discontinuation
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with immune-mediated adverse events (IMAEs)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to 2 years
Up to 2 years
Treatment prescribed to participants for immune-mediated adverse events (IMAEs)
Zeitfenster: Up to 2 years
Up to 2 years
Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation
Zeitfenster: Up to 2 years
Up to 2 years
Number of participants with treatment-related adverse events (TRAEs)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to 2 years
Up to 2 years
Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation
Zeitfenster: Up to 2 years
Up to 2 years
Duration of response (DOR)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: Up to 2 years
Up to 2 years
Number of participants receiving subsequent therapy
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bristol-Myers Squibb

Mitarbeiter

Ono Pharmaceutical Co., Ltd.

Ermittler

  • Studienleiter: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. März 2026

Primärer Abschluss (Geschätzt)

29. Februar 2028

Studienabschluss (Geschätzt)

29. Februar 2028

Studienanmeldedaten

Zuerst eingereicht

25. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

1. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CA209-1554

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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