AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
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.
Arms & interventions
- BiologicalPF-08634404
Solution for infusion
- BiologicalIpilimumab
Solution for infusion
Outcome measures
Primary
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.
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
Secondary
Phase 1b: Confirmed Objective Response Rate (ORR) using RECIST 1.1 as assessed by investigator
Time frame: Approximately 24 months
Duration of Response (DOR) per RECIST 1.1 by investigator
Time frame: Approximately 24 months
Progression Free Survival (PFS) per RECIST 1.1 by investigator
Time frame: Approximately 24 months
Overall Survival (OS)
Time frame: Approximately 24 months
Number of Participants With Clinical Laboratory Abnormalities
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
Time frame: Up to 24 months
Incidence of antidrug antibody against PF-08634404
Time frame: Up to 24 months
Eligibility criteria
Study locations (22)
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
Memorial Hospital
Shiloh, Illinois, 62269
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269
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
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
Siteman Cancer Center - North County
Florissant, Missouri, 63031
Siteman Cancer Center
St Louis, Missouri, 63108
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Siteman Cancer Center - South County
St Louis, Missouri, 63129
Renown Health Medical Oncology
Reno, Nevada, 89502
Renown Office of Clinical Research
Reno, Nevada, 89502
Renown Regional Medical Center
Reno, Nevada, 89502