At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed fibrolamellar hepatocellular cancer (FLC) that is metastatic or unresectable
- ✓DNAJB1-PRKACA fusion transcript positive confirmed by RNA-sequencing, DNA-sequencing, or in situ hybridization
- ✓Age >12 years for Cohorts A and B; ≥18 years for Cohort C
- ✓Body weight ≥40 kg for patients <18 years old in Cohorts A and B
- ✕Prior treatment with checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, anti-LAG-3) for Cohorts A and C
- ✕Prior unacceptable, life-threatening toxicity from immune therapy (Cohort B)
- ✕Chemotherapy, biological therapy, or radiation within 14 days prior to first dose
- ✕Surgery within 28 days of dosing, excluding minor procedures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma
In Brief
A Phase 1 clinical trial evaluating DNAJB1-PRKACA peptide vaccine, Nivolumab, and 1 other intervention for Fibrolamellar Hepatocellular Carcinoma (FLC). Currently recruiting, targeting 56 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
1. DNAJB1-PRKACA peptide vaccine: Day 1, 8, 15 of cycle 1 and on Day 1 of cycle 2, 3 and 4 (priming phase). Boost vaccinations: every 3 cycles beginning C5D1. 2. Drug: 0.3 mg DNAJB1-PRKACA peptide vaccine + 0.5mg Poly-ICLC
1. Nivolumab 3mg/kg will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycle 1-4 during the priming phase. Boost/maintenance vaccinations will be administered as a flat dose of 480mg every 4 weeks starting on Day 1 of Cycle 5. 2. Drug: 3mg/kg and 480mg IV
1. Ipilimumab (1 mg/kg) will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycles 1, 2, 3 and 4 of the study, every 3 weeks of the priming phase. 2. Drug: 1mg/kg IV