DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

April 20, 2020

Primary Completion Date

March 1, 2029

Study Completion Date

March 1, 2034

Conditions
Fibrolamellar Hepatocellular Carcinoma (FLC)
Interventions
DRUG

DNAJB1-PRKACA peptide vaccine

"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"

DRUG

Nivolumab

"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"

DRUG

Ipilimumab

"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"

Trial Locations (1)

21231

RECRUITING

Sidney Kimmel Comprehensive Cancer Center, Baltimore

All Listed Sponsors
collaborator

Fibrolamellar Cancer Foundation

OTHER

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER