NCT07227012

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_1

Timeline
30mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
4 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Dec 2025Oct 2028

First Submitted

Initial submission to the registry

November 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

November 7, 2025

Last Update Submit

April 17, 2026

Conditions

Hepatocellular CarcinomaUnresectable Hepatocellular CarcinomaLiver NeoplasmsAdvanced Hepatocellular CarcinomaMetastatic Hepatocellular CarcinomaCarcinoma, HepatocellularHepatocellular Cancer

Keywords

Hepatocellular CarcinomaLiver cancerLiver Neoplasms

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Adverse Events

    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)

    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

    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

    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

Secondary Outcomes (7)

  • Phase 1b: Confirmed Objective Response Rate (ORR) using RECIST 1.1 as assessed by investigator

    Approximately 24 months

  • Duration of Response (DOR) per RECIST 1.1 by investigator

    Approximately 24 months

  • Progression Free Survival (PFS) per RECIST 1.1 by investigator

    Approximately 24 months

  • Overall Survival (OS)

    Approximately 24 months

  • Number of Participants With Clinical Laboratory Abnormalities

    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)

  • +2 more secondary outcomes

Study Arms (2)

Phase 1b

EXPERIMENTAL

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

Biological: PF-08634404Biological: Ipilimumab

Phase 2

EXPERIMENTAL

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

Biological: PF-08634404Biological: Ipilimumab

Interventions

PF-08634404BIOLOGICAL

Solution for infusion

Phase 1bPhase 2
IpilimumabBIOLOGICAL

Solution for infusion

Also known as: YERVOY
Phase 1bPhase 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Renown Health Medical Oncology

Reno, Nevada, 89502, United States

RECRUITING

Renown Office of Clinical Research

Reno, Nevada, 89502, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

NOT YET RECRUITING

Kindai University Hospital- Osaka Medical Campus

Sakai, Osaka, 590-0197, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

RECRUITING

Pan American Center for Oncology Trials, LLC - Dorado Office

Dorado, United States of America, 00646, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, United States of America, 00680, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC

San Juan, 00909, Puerto Rico

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2025

First Posted

November 12, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

October 18, 2027

Study Completion (Estimated)

October 17, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

PR(4)US(3)JP(3)TW(1)