Timeframe: 2021 – 2022
Goal: Assess the potential of the combination of nivolumab, fluorouracil, and interferon alpha-2b as a treatment option for unresectable disease
Principal Investigators: Sunyoung Lee, MD and Ahmed Kaseb, MD, University of Texas M.D. Anderson Cancer Center
This phase I/II trial studies the side effects and how well the combination of nivolumab, fluorouracil, and interferon alpha-2b work for the treatment of fibrolamellar carcinoma (FLC) that cannot be removed by surgery. Immunotherapy with checkpoint inhibitors, 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. Treatment with a combination of nivolumab, fluorouracil, and interferon alpha-2b may work better in treating unresectable fibrolamellar cancer compared to treatment with fluorouracil and interferon alpha-2b alone. This clinical trial stages the drug administration and includes the analysis of “before and after” patient biopsies (samples of tumor tissue) to better understand how the drug combination may affect patients’ immune responses to FLC.