Clinical Trial for Carcinoma, Hepatocellular, Hepatocellular Cancer, Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Liver Neoplasms, Advanced Hepatocellular Carcinoma and Metastatic Hepatocellular Carcinoma.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Carcinoma, Hepatocellular, Hepatocellular Cancer, Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Liver Neoplasms, Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma

Sex

Male or Female

Age

18+ years

Healthy participants

Visit ClinicalTrials.gov for more information

Eligibility criteria

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.

Study overview

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.

View locations for this study

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Miles

0500

Nearest Locations found

11 sites found

Kindai University Hospital- Osaka Medical Campus

Sakai, Osaka, Japan, 590-0197

Recruiting

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National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan, 811-1395

Recruiting

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Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico, 00935

Recruiting

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Pan American Center for Oncology Trials, LLC

San Juan, Puerto Rico, 00909

Recruiting

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Pan American Center for Oncology Trials, LLC - Dorado Office

Dorado, United States of America, Puerto Rico, 00646

Recruiting

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Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, United States of America, Puerto Rico, 00680

Recruiting

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Renown Health Medical Oncology

Reno, Nevada, United States, 89502

Recruiting

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Renown Office of Clinical Research

Reno, Nevada, United States, 89502

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Renown Regional Medical Center

Reno, Nevada, United States, 89502

Recruiting

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Aichi Cancer Center

Nagoya, Aichi-ken, Japan, 464-8681

Not yet recruiting

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Taipei Veterans General Hospital

Taipei, Taiwan, 112

Not yet recruiting

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Join PfizerConnect

Symbiotic-GI-13: 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.

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

Symbiotic-GI-13: 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.

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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