Status: Not yet recruiting
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
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).
Participants needed: 27
Trial details
Phase: Phase 1Age: 12+Biological sex: AllType: InterventionalSponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUpdated: May 6, 2026Locations: 1
Eligibility criteria
Must have histologically confirmed FLC that is metastatic or unresectable. [+12]
Patients with a history of prior treatment with checkpoint inhibitors, such as a... [+26]