PF-08634404 alone or with ipilimumab for adults with advanced hepatocellular carcinoma not removable by surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional trial gives PF-08634404 intravenously either alone or combined with the checkpoint antibody ipilimumab to adults with locally advanced or metastatic hepatocellular carcinoma not amenable to curative surgery or locoregional therapy. Phase 1 focuses on safety, tolerability, and dose finding, followed by phase 2 to explore anti-tumor activity. Eligible participants must have measurable, untreated lesions, Child-Pugh A liver function, ECOG performance status 0–1, and no prior systemic therapy for HCC. Treatments are administered at clinical sites with monitoring during and after each infusion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chao Family Comprehensive Cancer Center and Ambulatory Care
  Irvine, California, United States Recruiting
• UCI Health - Irvine Infusion Pharmacy ACC
  Irvine, California, United States Recruiting
• UCI Health - Irvine
  Irvine, California, United States Recruiting
• START Los Angeles, LLC
  Los Angeles, California, United States Recruiting
• Keck Hospital of USC
  Los Angeles, California, United States Recruiting
• Los Angeles General Medical Center
  Los Angeles, California, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.