clinical trial · NCT07430202
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·phase1·not yet recruiting·n = 27
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))DNAJB1-PRKACA Peptide VaccineDRP-104NivolumabIpilimumab
brief summary
The purpose of this study is to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).
started
Sep 1, 2026
primary completion
Sep 1, 2030
completion
Sep 1, 2030
last updated
Aug 25, 2026
official title
A Phase 1b Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab for Patients With Advanced Stage Fibrolamellar Hepatocellular Carcinoma (FLC)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol