Study on Visugromab, Nivolumab, and a Tyrosine Kinase Inhibitor for Advanced Liver Cancer After Immunotherapy

Sponsor: CatalYm GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07219459

This clinical trial is testing a new combination of drugs, including visugromab, nivolumab, and a tyrosine kinase inhibitor (TKI), to see if they can help treat advanced liver cancer that cannot be removed by surgery and has not responded to previous immunotherapy treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new treatment combination for patients with advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed. The study will compare the effects of visugromab, nivolumab, and a TKI against a placebo and a TKI in patients whose cancer did not respond to a previous treatment that included an anti-PD-(L)1 drug. The trial is divided into two parts: an initial safety phase and a randomized phase with two treatment groups. Each group will include 40 participants to assess the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced liver cancer that cannot be removed by surgery.
  • Have measurable cancer as determined by medical imaging.
  • Previously treated with one line of systemic therapy that included an anti-PD-(L)1 drug for at least 12 weeks without cancer progression.
  • Aged 18 years or older.
  • Expected to live at least 3 more months.
  • In good general health with an ECOG performance status of 0 or 1.
  • Have a Child-Pugh score of A6 or better, indicating good liver function.

Exclusion Criteria

  • Have a specific type of liver cancer, such as fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma.
  • Have received more than one previous systemic treatment for advanced liver cancer.
  • Have had palliative radiation therapy within 28 days before starting the study treatment.
  • Need other cancer treatments during the trial.
  • Have active inflammatory bowel disease, diverticulitis, abdominal abscess, or bowel obstruction.
  • Have had another cancer unless treated and free of it for 5 years.
  • Have active cancer in the brain or central nervous system.
  • Have recent heart problems, such as a heart attack or stroke, or uncontrolled heart conditions.
  • Have an active autoimmune disease needing treatment in the past 3 months.
  • Are taking metformin for type II diabetes.
  • Are on long-term steroid treatment for other conditions.
  • Have had a liver or other organ transplant.

Get This Program In Your Inbox

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