RecruitingFibrolamellar Hepatocellular Carcinoma (FLC)
DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma
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 primary objective of the trial is the safety and tolerability of administering a vaccine targeting the DNAJB1-PRKACA fusion kinase, in combination with nivolumab and ipilimumab in patients with unresectable or metastatic FLC and with non-FLC solid tumors and to assess the T-cell response.
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
You may qualify if…
- ✓ Cohort A and B: Must have histologically confirmed FLC (fibrolamellar hepatocellular cancer) that is metastatic or unresectable.
- ✓ Cohort C: Patients with histologically proven metastatic or unresectable DNAJB1-PRKACA fusion transcript positive solid tumor malignancies, non-FLC solid tumors.
- ✓ Cohort A and B: Age \> 12 years. Note: Subjects age \> 12 years but \<18 are eligible to enroll only after 6 adult patients have enrolled on the study.
- ✓ Cohort A and B: Patients \< 18 years old must have a body weight ≥40 kg.
- ✓ Cohort C: Patients must be Age ≥ 18 years.
- ✓ All Cohorts:
- ✓ Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.
- ✓ ECOG performance status of ≤2 (Karnofsky ≥60%)
You may not qualify if…
- ✕ Cohort A and C: 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. NOTE: Prior therapy with interferon-alpha is allowed.
- ✕ Cohort B: Participants a with history of unacceptable, life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment, any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
- ✕ All Cohorts:
- ✕ Have had chemotherapy or other systemic therapy or radiotherapy, as follows:
- ✕ Have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug.
- ✕ Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.
- ✕ Have received other approved or investigational agents or device within 28 days of the first dose of study drug.
- ✕ Have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered.
Where it's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT04248569 · last updated 2025-12-03