Study on Visugromab, Nivolumab, and a Tyrosine Kinase Inhibitor for Advanced Liver Cancer After Immunotherapy
Sponsor: CatalYm GmbH
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
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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.
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