Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver Cancer

Summary

This phase II trial studies the best dose and side effects of sorafenib tosylate and nivolumab in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and nivolumab may work better in treating patients with liver cancer.

Timeline

Start

2018-04-16

Primary completion

2023-11-30

Completion

2023-11-30

Publications

• Keenan BP, Fan Z, Le BK, Harris Q, Chen J, Clark M, Lea A, Zhang L, Cheung A, Lara F, Gordan JD, Bracci P, Behr SC, Fong L, Venook AP, Kim EJ, Kelley RK. Phase II trial with nivolumab and sorafenib in HCC identified enrichment of immunosuppressive monocytes in patients with Child-Pugh B liver dysfunction. JHEP Rep. 2026 May;8(5):101817. doi: 10.1016/j.jhepr.2026.101817. Epub 2026 Mar 12.

Drugs

Indications