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).

Trial Details

NCT ID

NCT07430202

Phase

PHASE1

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

RECRUITING

Cancer Type

Liver Cancer

Interventions

DNAJB1-PRKACA Peptide Vaccine
DRP-104
Nivolumab
Ipilimumab

Locations (sample)

Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

Must have histologically confirmed FLC that is metastatic or unresectable.
Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.
Must have demonstrated radiographic progression on prior or current immunotherapy.
Age ≥ 12 years.

For full eligibility, visit ClinicalTrials.gov.

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