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).
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.
Patients with a history of prior treatment with checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies.
Patients who have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug.
Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures.
Patients who have received other approved or investigational agents or device within 28 days of the first dose of study drug.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Dracen Pharmaceuticals, Inc.
Collaborator
Cancer Research Institute, New York City
Collaborator
Fibrolamellar Cancer Foundation
Collaborator