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

25 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

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

Backup dei contatti dello studio

  • Nome: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Numero di telefono: 855-907-3286
  • Email: Clinical.Trials@bms.com

Luoghi di studio

  • Giappone
      • Chiba, Giappone
        • Reclutamento
        • National Cancer Center Hospital East
    • Tokyo
      • Minato-ku, Tokyo, Giappone, 1050001
        • Reclutamento
        • Mebix. Inc
        • Contatto:
          • Minoru Tonogai, Site 0001

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Nivolumab plus ipilimumab cohort
Participants with unresectable hepatocellular carcinoma receiving nivolumab plus ipilimumab as first-line systemic therapy in routine clinical practice in Japan.
Prodotto combinato: Nivolumab plus ipilimumab
According to product label

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with grade ≥3 immune-mediated liver injury (IMLI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Up to 2 years
Up to 2 years
Treatment prescribed to participants for immune-mediated liver injury (IMLI)
Lasso di tempo: Up to 2 years
Up to 2 years
Objective response rate (ORR)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 2 years
Number of participants who discontinue nivolumab plus ipilimumab.
Up to 2 years
Reasons for treatment discontinuation
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with immune-mediated adverse events (IMAEs)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Up to 2 years
Up to 2 years
Treatment prescribed to participants for immune-mediated adverse events (IMAEs)
Lasso di tempo: Up to 2 years
Up to 2 years
Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation
Lasso di tempo: Up to 2 years
Up to 2 years
Number of participants with treatment-related adverse events (TRAEs)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Up to 2 years
Up to 2 years
Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation
Lasso di tempo: Up to 2 years
Up to 2 years
Duration of response (DOR)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: Up to 2 years
Up to 2 years
Number of participants receiving subsequent therapy
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Collaboratori

Ono Pharmaceutical Co., Ltd.

Investigatori

  • Direttore dello studio: Bristol-Myers Squibb, Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 marzo 2026

Completamento primario (Stimato)

29 febbraio 2028

Completamento dello studio (Stimato)

29 febbraio 2028

Date di iscrizione allo studio

Primo inviato

25 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CA209-1554

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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