A new clinical trial for fibrolamellar carcinoma (FLC) is now recruiting subjects at the University of Texas M.D. Anderson Cancer Center in Houston, Texas. This phase I/II trial studies the safety, tolerability, and effectiveness of a combination of nivolumab, 5-fluorouracil (5-FU), and interferon alpha-2b (IFN-α2b) for the treatment of fibrolamellar cancer 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, 5-FU, and IFN-α2b may work better in treating unresectable fibrolamellar cancer compared to treatment with 5-FU and IFN-α2b alone. The study asks if the direct cytotoxic effects of the combination of 5-FU and IFN-α2b may synergize with nivolumab to create potent anti-tumor immunity. This clinical trial includes the analysis of patient biopsies (“before and after” samples of tumor tissue) to better understand how the drug combination may affect patients’ immune responses to FLC.
Enrollment in this trial is open to FLC patients 12 years old and older. The study’s principal investigator is Dr. Sunyoung Lee at M.D. Anderson Cancer Center; Dr. Ahmed Kaseb at M.D. Anderson Cancer Center is the co-investigator. Additional details and contact information can be found at: https://clinicaltrials.gov/ct2/show/NCT04380545