Study on PF-08634404 for Advanced Liver Cancer (Hepatocellular Carcinoma)

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT07227012

This clinical trial is exploring a new treatment, PF-08634404, given alone or with another drug, ipilimumab, for adults with advanced liver cancer that cannot be removed by surgery and may have spread to other parts of the body.

Patient Parameters

Program Overview

The aim of this study is to understand how a new medicine, PF-08634404, works when used alone or with ipilimumab in treating advanced liver cancer, known as hepatocellular carcinoma (HCC). This type of cancer has either spread to nearby tissues or other parts of the body and cannot be completely removed by surgery. Participants will receive the treatment through an IV, which means the medicine will be given directly into a vein. All treatments will be conducted at clinical trial sites, where medical staff will closely monitor participants.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have advanced liver cancer (HCC) that has spread locally or to other parts of the body, confirmed by medical tests.
  • The cancer cannot be completely removed by surgery or has worsened after surgery or other local treatments.
  • Have at least one measurable tumor that has not been treated.
  • Have good liver and kidney function.
  • Have not received any previous whole-body treatment for liver cancer.
  • Be in good general health, with a performance status score of 0 or 1.
  • Have a Child-Pugh Class A liver function score.

Exclusion Criteria

  • Have moderate or severe fluid buildup in the abdomen (ascites).
  • Have a history of brain-related liver disease (hepatic encephalopathy).
  • Have active cancer spread to the brain or spinal cord.
  • Have a high risk of bleeding or abnormal connections between organs (fistula).
  • Have had another cancer within the last 3 years.
  • Have had an organ or stem cell transplant.
  • Have active autoimmune diseases needing treatment in the past 2 years.
  • Have significant heart disease within the last 6 months.
  • Have had major surgery or severe injury within 4 weeks before starting the study or plan to have major surgery during the study.
  • Have a history of severe bleeding disorders or blood clotting issues.
  • Have severe ulcers, unhealed wounds, or recent serious gastrointestinal issues.
  • Have active or chronic infections.
  • Have a history of immune system deficiencies.

Locations

FACILITYZIPCITYSTATE
Moffitt Cancer Center at Speros34638Land O' LakesFlorida
Moffitt Cancer Center at SouthShore33570RuskinFlorida
Moffitt Cancer Center - International Plaza33607TampaFlorida
Moffitt Cancer Center - McKinley Campus33612TampaFlorida
Moffitt Cancer Center33612TampaFlorida
Moffitt McKinley Hospital33612TampaFlorida
Moffitt Cancer Center at Wesley Chapel33544Wesley ChapelFlorida
Memorial Hospital62269ShilohIllinois
Siteman Cancer Center - Shiloh62269ShilohIllinois
Allina Health Cancer Institute - Mercy Hospital55433Coon RapidsMinnesota

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