A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.
NCT ID: NCT07227012
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
138 participants
INTERVENTIONAL
2025-12-01
2028-10-17
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1b
Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.
PF-08634404
Solution for infusion
Ipilimumab
Solution for infusion
Phase 2
Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.
PF-08634404
Solution for infusion
Ipilimumab
Solution for infusion
Interventions
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PF-08634404
Solution for infusion
Ipilimumab
Solution for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2025-523525-17-00
Identifier Type: CTIS
Identifier Source: secondary_id
C6461013
Identifier Type: -
Identifier Source: org_study_id