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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1b 		Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.
  • Biological: PF-08634404
    Solution for infusion
  • Biological: Ipilimumab
    Solution for infusion
    Other names:
    • YERVOY
Experimental
Phase 2 		Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.
  • Biological: PF-08634404
    Solution for infusion
  • Biological: Ipilimumab
    Solution for infusion
    Other names:
    • YERVOY

Recruiting Locations

Moffitt Cancer Center at Speros
Land O' Lakes, Florida 34638

Moffitt Cancer Center at SouthShore
Ruskin, Florida 33570

Moffitt Cancer Center - International Plaza
Tampa, Florida 33607

Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612

Moffitt Cancer Center
Tampa, Florida 33612

Moffitt McKinley Hospital
Tampa, Florida 33612

Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544

Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota 55433

Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota 55407

Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota 55102

Renown Health Medical Oncology
Reno, Nevada 89502

Renown Office of Clinical Research
Reno, Nevada 89502

Renown Regional Medical Center
Reno, Nevada 89502

Pan American Center for Oncology Trials, LLC - Dorado Office
Dorado, United States of America, Puerto Rico 00646

Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, United States of America, Puerto Rico 00680

Pan American Center for Oncology Trials, LLC - Ponce Office
Ponce, United States of America, Puerto Rico 00730

Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico 00935

Pan American Center for Oncology Trials, LLC
San Juan, Puerto Rico 00909

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.