RecruitingLiver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Eligible age
12+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
You may qualify if…
- ✓ 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 \< 18 years old must have a body weight ≥ 40 kg.
- ✓ ECOG (Eastern Cooperative Oncology Group) performance status of ≤2
- ✓ Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- ✓ Patients must have adequate kidney and liver function defined by study-specified laboratory tests.
You may not qualify if…
- ✕ 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.
- ✕ Must have had chemotherapy or other systemic therapy or radiotherapy, as follows:
- ✕ 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.
- ✕ Patients who have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered, with exception of grade 2 fatigue, rash, and endocrinopathy successfully managed hormone replacement therapy, or alopecia or stable neuropathy, unless approved by the IND Sponsor.
- ✕ Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.
- ✕ Known sensitivity to or history of allergic reactions attributed to compounds of similar chemical or biologic composition of polyinosinic-polycytidylic acid (Poly-ICLC) and/or DRP-104 and/or nivolumab and/or ipilimumab.
Where it's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT07430202 · last updated 2026-10-05