Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab

Trial snapshot

  • Formal name: DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma
  • Trial type: Specifically designed for fibrolamellar carcinoma
  • Phase: Phase I
  • Recruitment status: Active, Recruiting
  • Eligible ages: 12+
  • Location: Baltimore, MD (Johns Hopkins – Sidney Kimmel Comprehensive Cancer Center)
  • ClinicalTrials.gov ID: NCT04248569

Overview

This phase I clinical trial of an immune therapy for fibrolamellar carcinoma (FLC) is now recruiting subjects at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, MD. The study asks if 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 (the first patient in the trial received this vaccine on April 21, 2020) 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.

Trial eligibility

Enrollment in this trial is open to FLC patients 12 years old and older. The study’s principal investigator is Dr. Mark Yarchoan. More detail can be found at: https://www.clinicaltrials.gov/study/NCT04248569.

Dr. Mark Yarchoan, the principal investigator of this trial, discusses the rationale for the FLC fusion peptide vaccine, the accompanying drug regimen and the eligibility criteria for this first-in-human study in the video below:

Trial contact information:

Please visit clinicaltrials.gov for a comprehensive list of active trials. 

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