A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Starting soon · Phase 1
Conditions studied: Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
In brief
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).
Key facts
- Study ID
- NCT07430202
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 27
- Starts
- 2026-08-01
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
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.
- Must have measurable disease per RECIST 1.1
- Willingness to provide tissue and blood samples for mandatory translational research.
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
- For both Women and Men, must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
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.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Has an active autoimmune disease.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Has a diagnosis of immunodeficiency.
- Systemic corticosteroids at immunosuppressive doses.
- Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- Has a pulse oximetry of <92% on room air or is on supplemental home oxygen.
- Active or untreated brain metastases or leptomeningeal metastases.
- Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding.
- Has a known history of Human Immunodeficiency Virus (HIV)/AIDS.
- Has active hepatitis B. Patients with chronic or acute HBV infection.
- Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study.
- Unwilling or unable to follow the study schedule for any reason.
- Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
- Evidence of clinical ascites.
Where it is running
- Johns Hopkins SKCCC — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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