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En studie för att lära sig om studieläkemedlet PF-08634404 som enkelbehandling och kombinationsbehandling hos vuxna deltagare med en levercancer som kallas hepatocellulärt karcinom, som är för avancerad för att kunna avlägsnas genom kirurgi och som kan ha spridit sig till andra delar av kroppen.

6 oktober 2026 uppdaterad av: Pfizer

EN INTERVENTIONELL ÖPPEN FÄRGAD FAS 1B/2-STUDIE FÖR ATT UTVÄRDERA SÄKERHET, FARMAKOKINETIK OCH PRELIMINÄR EFFEKT AV PF-08634404 SOM MONOTERAPI OCH KOMBINATIONSTERAPI HOS VUXNA DELTAGARE MED OPRERABEL LOKALT AVANCERAD ELLER METASTASERAD HEPATOCELLULÄR KARCINOM

The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.

To join the study, participants must meet the following conditions:

  • Be 18 years or older.
  • Have locally advanced or metastatic HCC.
  • Is not a candidate for complete surgical or loco-regional therapies.
  • Have not received any whole-body treatment for HCC.

Participants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

138

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • Irvine, California, Förenta staterna, 92612
        • Rekrytering
        • Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Irvine, California, Förenta staterna, 92612
        • Rekrytering
        • UCI Health - Irvine Infusion Pharmacy ACC
      • Irvine, California, Förenta staterna, 92612
        • Rekrytering
        • UCI Health - Irvine
      • Los Angeles, California, Förenta staterna, 90033
        • Rekrytering
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Förenta staterna, 90033
        • Rekrytering
        • Keck Hospital of USC
      • Los Angeles, California, Förenta staterna, 90033
        • Rekrytering
        • USC/Norris Comprehensive Cancer Center / Investigational Drug Services
      • Los Angeles, California, Förenta staterna, 90033
        • Rekrytering
        • Los Angeles General Medical Center
      • Los Angeles, California, Förenta staterna, 90025
        • Rekrytering
        • START Los Angeles, LLC
      • Los Angeles, California, Förenta staterna, 90067
        • Rekrytering
        • LACN Century City
      • Orange, California, Förenta staterna, 92868
        • Rekrytering
        • UC Irvine Health - Chao Family Comprehensive Cancer Center
      • Pasadena, California, Förenta staterna, 91105
        • Rekrytering
        • Keck Medical Center of USC Pasadena
    • Florida
      • Land O' Lakes, Florida, Förenta staterna, 34638
        • Rekrytering
        • Moffitt Cancer Center at Speros
      • Ruskin, Florida, Förenta staterna, 33570
        • Rekrytering
        • Moffitt Cancer Center at SouthShore
      • Tampa, Florida, Förenta staterna, 33612
        • Rekrytering
        • Moffitt Cancer Center - McKinley Campus
      • Tampa, Florida, Förenta staterna, 33612
        • Rekrytering
        • Moffitt Cancer Center
      • Tampa, Florida, Förenta staterna, 33612
        • Rekrytering
        • Moffitt McKinley Hospital
      • Tampa, Florida, Förenta staterna, 33607
        • Rekrytering
        • Moffitt Cancer Center - International Plaza
      • Wesley Chapel, Florida, Förenta staterna, 33544
        • Rekrytering
        • Moffitt Cancer Center at Wesley Chapel
    • Illinois
      • Shiloh, Illinois, Förenta staterna, 62269
        • Rekrytering
        • Siteman Cancer Center - Shiloh
      • Shiloh, Illinois, Förenta staterna, 62269
        • Rekrytering
        • Memorial Hospital
    • Minnesota
      • Coon Rapids, Minnesota, Förenta staterna, 55433
        • Rekrytering
        • Allina Health Cancer Institute - Mercy Hospital
      • Minneapolis, Minnesota, Förenta staterna, 55407
        • Rekrytering
        • Allina Health Cancer Institute - Abbott Northwestern Hospital
      • Saint Paul, Minnesota, Förenta staterna, 55102
        • Rekrytering
        • Allina Health Cancer Institute - United Hospital
    • Missouri
      • City of Saint Peters, Missouri, Förenta staterna, 63376
        • Rekrytering
        • Siteman Cancer Center - St. Peters
      • Creve Coeur, Missouri, Förenta staterna, 63141
        • Rekrytering
        • Siteman Cancer Center - West County
      • Florissant, Missouri, Förenta staterna, 63031
        • Rekrytering
        • Siteman Cancer Center - North County
      • Kansas City, Missouri, Förenta staterna, 64111
        • Rekrytering
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, Förenta staterna, 64111
        • Rekrytering
        • Saint Luke's Cancer Institute
      • St Louis, Missouri, Förenta staterna, 63108
        • Rekrytering
        • Siteman Cancer Center
      • St Louis, Missouri, Förenta staterna, 63110
        • Rekrytering
        • Washington University School of Medicine - Siteman Cancer Center
      • St Louis, Missouri, Förenta staterna, 63110
        • Rekrytering
        • Barnes-Jewish Hospital
      • St Louis, Missouri, Förenta staterna, 63129
        • Rekrytering
        • Siteman Cancer Center - South County
    • Nevada
      • Reno, Nevada, Förenta staterna, 89502
        • Rekrytering
        • Renown Regional Medical Center
      • Reno, Nevada, Förenta staterna, 89502
        • Rekrytering
        • Renown Health Medical Oncology
      • Reno, Nevada, Förenta staterna, 89502
        • Rekrytering
        • Renown Office of Clinical Research
    • North Carolina
      • Cary, North Carolina, Förenta staterna, 27518
        • Rekrytering
        • Duke Cancer Center Cary
      • Durham, North Carolina, Förenta staterna, 27710
        • Rekrytering
        • Duke Cancer Center
      • Durham, North Carolina, Förenta staterna, 27710
        • Rekrytering
        • Duke University - Main Hospital and Clinics
      • Durham, North Carolina, Förenta staterna, 27710
        • Rekrytering
        • Duke Cancer Center - Investigational Chemotherapy Service
      • Raleigh, North Carolina, Förenta staterna, 27609
        • Rekrytering
        • Duke Cancer Center Raleigh
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44106
        • Rekrytering
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15212
        • Rekrytering
        • AHN Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Förenta staterna, 15212
        • Rekrytering
        • AHN Cancer Institute at Allegheny General Hospital
    • Washington
      • Seattle, Washington, Förenta staterna, 98101
        • Rekrytering
        • Virginia Mason Medical Center
      • Seattle, Washington, Förenta staterna, 98109
        • Rekrytering
        • Fred Hutchinson Cancer Center
      • Seattle, Washington, Förenta staterna, 98195
        • Rekrytering
        • University of Washington Medical Center- Montlake
  • Japan
      • Fukuoka, Japan, 811-1395
        • Rekrytering
        • National Hospital Organization Kyushu Cancer Center
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Rekrytering
        • Aichi Cancer Center
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Rekrytering
        • National Cancer Center Hospital East
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Rekrytering
        • Kindai University Hospital- Osaka Medical Campus
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Rekrytering
        • National Cancer Center Hospital
  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Rekrytering
        • Zhongshan Hospital,Fudan University
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Rekrytering
        • Pan American Center for Oncology Trials, LLC
    • United States of America
      • Dorado, United States of America, Puerto Rico, 00646
        • Rekrytering
        • Pan American Center for Oncology Trials, LLC - Dorado Office
      • Mayagüez, United States of America, Puerto Rico, 00680
        • Rekrytering
        • Pan American Center for Oncology Trials, LLC - Mayaguez Office
      • Ponce, United States of America, Puerto Rico, 00730
        • Rekrytering
        • Pan American Center for Oncology Trials, LLC - Ponce Office
  • Taiwan
      • Taichung, Taiwan, 407
        • Rekrytering
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • Rekrytering
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • Rekrytering
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Rekrytering
        • Taipei Veterans General Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 18 years of age or older at screening.
  • Locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.
  • Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies.
  • At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.
  • Adequate hepatic, liver, and renal function
  • No prior systemic therapy for HCC.
  • ECOG performance status 0 or 1
  • Child-Pugh Class A

Key Exclusion Criteria:

  • Moderate or severe ascites.
  • History of hepatic encephalopathy.
  • Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
  • Clinically significant risk of hemorrhage or fistula.
  • Participants with any history of another malignancy within 3 years.
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.
  • Clinically significant cardiovascular disease within 6 months prior to the first dose.
  • Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.
  • History of severe bleeding tendency or coagulation dysfunction.
  • History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and/or gastric varices, within 6 months prior to the first dose.
  • Participants with acute, chronic or symptomatic infections.
  • Participants with history of immunodeficiency.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Phase 1b

Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.
Biologisk: PF-08634404

Solution for infusion

Biologisk: Ipilimumab

Solution for infusion

Andra namn:
  • YERVOY
Experimentell: Phase 2

Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.
Biologisk: PF-08634404

Solution for infusion

Biologisk: Ipilimumab

Solution for infusion

Andra namn:
  • YERVOY

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events
Tidsram: Through end of study and up to approximately 24 months

Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Through end of study and up to approximately 24 months
Phase 1b: Number of participants with Dose limiting toxicities (DLT)
Tidsram: Through 90 days after the last dose of study intervention; Approximately 24 months

DLTs are a predefined set of adverse events that are at least possibly related to any or all of the study interventions. The number of participants who experienced DLTs during the DLT observation period.
Through 90 days after the last dose of study intervention; Approximately 24 months
Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator
Tidsram: Approximately 24 months

ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.
Approximately 24 months
Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab
Tidsram: Approximately 24 months

The doses of PF-08634404 and ipilimumab selected to be used in combination based on safety, tolerability, pharmacokinetics, and initial anti-tumor efficacy from Phase 2.
Approximately 24 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase 1b: Confirmed Objective Response Rate (ORR) using RECIST 1.1 as assessed by investigator
Tidsram: Approximately 24 months

ORR is the proportion of participants with a best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST 1.1 by investigator.
Approximately 24 months
Duration of Response (DOR) per RECIST 1.1 by investigator
Tidsram: Approximately 24 months

DOR is the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.
Approximately 24 months
Progression Free Survival (PFS) per RECIST 1.1 by investigator
Tidsram: Approximately 24 months

PFS is defined as the time from the date of first dose to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.
Approximately 24 months
Overall Survival (OS)
Tidsram: Approximately 24 months

OS is defined as the time from the date of first dose to the date of death due to any cause.
Approximately 24 months
Number of Participants With Clinical Laboratory Abnormalities
Tidsram: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (assessed up to approximately 24 months)

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (assessed up to approximately 24 months)
Pharmacokinetics (PK): Serum concentrations of PF-08634404
Tidsram: Up to 24 months

Predose and/or postdose concentrations of PF-08634404 in combination with ipilimumab.
Up to 24 months
Incidence of antidrug antibody against PF-08634404
Tidsram: Up to 24 months

To evaluate immunogenicity of PF-08634404 in combination with ipilimumab.
Up to 24 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Utredare

  • Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 december 2025

Primärt slutförande (Beräknad)

18 oktober 2027

Avslutad studie (Beräknad)

17 oktober 2028

Studieregistreringsdatum

Först inskickad

7 november 2025

Först inskickad som uppfyllde QC-kriterierna

7 november 2025

Första postat (Faktisk)

12 november 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C6461013
  • 2025-523525-17-00 (Ctis)
  • Symbiotic-GI-13 (Annan identifierare: Pfizer)
  • 2025 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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