Study on ABX196 and Nivolumab for Patients with Liver Cancer (Hepatocellular Carcinoma)

Sponsor: Abivax S.A.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03897543

Provider View

This clinical trial is testing a new treatment combining ABX196 and nivolumab to see if it is safe and effective for patients with liver cancer that cannot be treated with surgery or local therapies.

Patient Parameters

Program Overview

The study aims to find out if a combination of two drugs, ABX196 and nivolumab, is safe and can help treat liver cancer (hepatocellular carcinoma) that cannot be removed by surgery or treated with local therapies. The trial is divided into two parts: the first part will test different doses to find the safest one, and the second part will expand the study to more patients to see how well the treatment works.

Description

This clinical trial is exploring a new treatment for liver cancer that cannot be treated with surgery or local therapies. The study involves two drugs: ABX196, which is given as an injection, and nivolumab, which is given through an IV. The trial is divided into two phases. In the first phase, researchers will test different doses of ABX196 to find the safest one. In the second phase, more patients will receive the treatment to see how well it works. Nivolumab is given every two weeks, and ABX196 is given every eight weeks. The study will monitor patients for any side effects and measure how the cancer responds to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with liver cancer that cannot be treated with surgery or local therapies.
  • Cancer has progressed after previous treatments or the patient cannot tolerate or refuses certain medications.
  • Have had at least one prior treatment for liver cancer.
  • Eligible to receive nivolumab treatment.
  • Have measurable cancer based on specific criteria.
  • Have a Child-Pugh class A liver score within 7 days before starting the study.
  • No history of severe liver-related conditions like hepatic encephalopathy.
  • No significant fluid buildup in the abdomen that requires treatment.
  • If infected with hepatitis B, must have been on antiviral therapy for at least 12 weeks and have a low viral load.
  • No active co-infections with hepatitis B and C or hepatitis B and D.
  • No active drug or alcohol abuse.

Exclusion Criteria

  • Have taken certain cancer medications within 2 weeks before starting the study.
  • Have had bleeding from esophageal or stomach veins in the past 6 months.
  • Have cancer that has spread to major blood vessels or the heart.
  • Have had an organ or bone marrow transplant.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have an immune deficiency or are taking immune-suppressing medications within 7 days before starting the study.
  • Have had major liver surgery or treatment within 6 weeks before starting the study.
  • Have had minor surgery to the liver or another area within 1 week before starting the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.