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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Solution for infusion
Solution for infusion
Pan American Center for Oncology Trials, LLC
San Juan, Other, Puerto Rico
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 24 months
Phase 1b: Confirmed Objective Response Rate (ORR) using RECIST 1.1 as assessed by investigator
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.
Time frame: Approximately 24 months
Duration of Response (DOR) per RECIST 1.1 by investigator
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.
Time frame: Approximately 24 months
Progression Free Survival (PFS) per RECIST 1.1 by investigator
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.
Time frame: Approximately 24 months
Overall Survival (OS)
OS is defined as the time from the date of first dose to the date of death due to any cause.
Time frame: Approximately 24 months
Number of Participants With Clinical Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Time frame: 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
Predose and/or postdose concentrations of PF-08634404 in combination with ipilimumab.
Time frame: Up to 24 months
Incidence of antidrug antibody against PF-08634404
To evaluate immunogenicity of PF-08634404 in combination with ipilimumab.
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.