The clinical trials listed on this page are specifically designed for patients with fibrolamellar carcinoma (FLC), based on pre-clinical research.
Trials Currently Recruiting FLC Patients
● Peptide Vaccine Combined with Glutamine Antagonist DRP-104, Nivolumab and Ipilimumab
- Formal name: DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined with Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients with Advanced Stage FLC
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I
- Recruitment status: Active, recruiting
- Eligible ages: 12+
- Location: Baltimore, MD (Johns Hopkins – Sidney Kimmel Comprehensive Cancer Center)
- ClinicalTrials.gov ID: NCT07430202
- Detail page: View trial details
This phase Ib immunotherapy trial investigates if the addition of the glutamine antagonist DRP-104 to an anti-cancer vaccine therapy that has already helped several FLC patients can improve its effectiveness.
● FusionVAC22_01: Fusion Transcript‑Based Peptide Vaccine and Atezolizumab
- Formal name: FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined With Immune Checkpoint Inhibition (FusionVAC22)
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I
- Recruitment status: Active, recruiting
- Eligible ages: 18+
- Location: Tübingen, Germany (University Hospital Tübingen and partner centers)
- ClinicalTrials.gov ID: NCT05937295
- Detail page: View trial details
This study evaluates the ability of a DNAJB1‑PRKACA fusion transcript‑based peptide vaccine (Fusion‑VAC‑XS15) administered with the checkpoint inhibitor atezolizumab to stimulate a targeted immune response against FLC cells.
● FusionVAC22_02: Peptide Vaccine for FLC Driver Fusion
- Formal name: FusionVAC22_02: Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I
- Recruitment status: Active, recruiting
- Eligible ages: 18+
- Location: Tübingen, Germany (University Hospital Tübingen)
- ClinicalTrials.gov ID: NCT06789198
- Detail page: View trial details
This study evaluates the effectiveness of a DNAJB1‑PRKACA fusion transcript‑based peptide vaccine (Fusion‑VAC‑XS15) to prevent disease recurrence in patients who have no radiological evidence of disease after successful surgery or other treatment.
● DT2216 in Combination with Irinotecan
- Formal name: DT2216 in Combination with Irinotecan for Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors: A Phase I Study with Phase II Feasibility Cohort for Fibrolamellar Carcinoma
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I
- Recruitment status: Active, recruiting
- Eligible ages: <19
- Locations: 21 sites within the Pediatric Early Phase‑Clinical Trial Network (PEP‑CTN)
- ClinicalTrials.gov reference: NCT06620302
- Detail page: View trial details
This study evaluates DT2216, a targeted therapy, administered along with irinotecan, a traditional chemotherapy agent. The current Phase I stage is open to fibrolamellar patients, as well as patients with any solid tumor. Phase II, anticipated to open in 2Q2027, will be open only to patients with fibrolamellar carcinoma of ages <39.
● Nivolumab, Fluorouracil, and Interferon Alpha-2B
- Formal name: A Phase I/II Study of Nivolumab Plus 5-Fluorouracil Plus Interferon-α2b for Unresectable Fibrolamellar Hepatocellular Carcinoma
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I/II
- Recruitment status: Active, recruiting
- Eligible ages: 12 years and older
- Locations: Houston, TX (M.D. Anderson Cancer Center)
- ClinicalTrials.gov reference: NCT04380545
- Detail page: View trial details
This study, begun in 2020, is evaluating the effectiveness of the combination of nivolumab, fluorouracil, and interferon alpha-2b for the treatment of FLC that cannot be removed by surgery.
Trials Closed to New Recruitment
● DRP‑104 (Glutamine Antagonist) Combined with Durvalumab
- Formal name: DRP-104 (Glutamine Antagonist) in Combination with Durvalumab in Patients with Advanced Stage Fibrolamellar Carinoma (FLC)
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I
- Recruitment status: Active, not recruiting
- Eligible ages: 12+
- Location: Baltimore, MD (Johns Hopkins – Sidney Kimmel Comprehensive Cancer Center)
- ClinicalTrials.gov ID: NCT06027086
- Detail page: View trial details
This phase I trial evaluates the safety and activity of the experimental prodrug DRP‑104, a glutamine antagonist, in combination with the immune checkpoint inhibitor durvalumab, in patients with advanced fibrolamellar carcinoma. The treatment tested in this trial is being combined with the peptide vaccine in the follow-on trial NCT07430202 that is now recruiting patients.
● Fusion Kinase Peptide Vaccine Combined with Nivolumab and Ipilimumab
- Formal name: DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I
- Recruitment status: Active, not recruiting
- Eligible ages: 12+
- Locations: Baltimore, MD (Johns Hopkins – Sidney Kimmel Comprehensive Cancer Center)
- ClinicalTrials.gov reference: NCT04248569
- Detail page: View trial details
This phase I immunotherapy trial investigates the ability to stimulate a targeted immune response against FLC tumors by targeting the DNAJB1‑PRKACA fusion protein using a peptide vaccine combined with immune checkpoint inhibition. The treatment tested in this trial is being combined with a glutamine antagonist in the follow-on trial NCT07430202 that is now recruiting patients.
Important Notes
- Trial availability, eligibility criteria, and recruitment status may change; please visit clinicaltrials.gov for a comprehensive list of active trials.
- Always confirm enrollment status directly with the clinical trial team or your treating physician.
The Fibrolamellar Cancer Foundation does not provide medical advice. We provide website users with information to help them better understand their health conditions and current approaches towards diagnosis, treatment and supportive care. Always seek the advice of your physician or other qualified healthcare provider.