Timeframe: 2020 – 2022
Goal: Assess potential to induce immune response with a FLC therapeutic vaccine
Principal Investigator: Mark Yarchoan, MD, Associate Professor, Oncology/Division of GI Malignancies, Sidney Kimmel Comprehensive Cancer Center
This clinical trial of an immune therapy for fibrolamellar carcinoma (FLC) is recruiting subjects at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, MD. The study investigates whether individuals can mount an effective immune response against FLC by specifically targeting the unique chimeric protein (resulting from a DNAJB1-PRKACA gene fusion) believed to drive the growth of almost all such tumors. Trial subjects will be given an experimental vaccine containing a peptide (small segment of a protein) that corresponds to the junction region linking the two parts of the chimeric protein. They will simultaneously receive two FDA-approved drugs, Opdivo (nivolumab) and Yervoy (ipilimumab), that may enhance the immune response against FLC by overcoming “checkpoint” systems that can limit the immune system’s ability to fight a cancer. Details and contact information can be found at: https://www.clinicaltrials.gov/ct2/show/NCT-04248569