Cemiplimab +/- Fianlimab for Liver Cancer

(CLeAR Trial)

This trial examines the effectiveness of two treatments for liver cancer: cemiplimab alone and cemiplimab with fianlimab. Researchers aim to determine if these treatments are effective after yttrium-90 (Y90) radiation therapy. The trial is open to individuals with liver cancer confirmed through imaging or biopsy who have already undergone or are eligible for Y90 treatment. Those with liver cancer primarily in the liver, for whom surgery or liver transplants are not options, may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

The trial does not specify if you need to stop taking your current medications. However, you cannot use immunosuppressive medications within 14 days before starting the study treatment, except for certain low-dose steroids and topical or inhaled steroids.

Studies have shown that cemiplimab is generally well-tolerated. In a group of 810 patients, only 2% developed immune-related hepatitis, a type of liver inflammation. Although some patients experienced liver damage, this was rare.

Research on the combination of cemiplimab and fianlimab also suggests it is relatively safe. One study found that 43.9% of patients had significant side effects, and 32.7% experienced serious side effects. However, these side effects are typical for cancer treatments and were considered manageable.

Researchers are excited about cemiplimab and fianlimab for liver cancer because they represent a new approach compared to the usual treatments like sorafenib and lenvatinib. Cemiplimab is a monoclonal antibody that blocks the PD-1 pathway, which helps the immune system attack cancer cells more effectively. When combined with fianlimab, which targets LAG-3, another immune checkpoint, this duo aims to enhance the body's immune response even further. This combination strategy could potentially lead to better outcomes for patients by tackling the cancer from two different angles.

Research has shown that cemiplimab, which participants in this trial may receive, offers promising results for treating liver cancer. One study found that patients with resectable hepatocellular carcinoma experienced significant tumor shrinkage. Specifically, about 20% of these patients had over 70% of their cancer cells die, suggesting that cemiplimab might make tumors easier to remove surgically.