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

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.

Trial Details

NCT ID

NCT04248569

Phase

PHASE1

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

RECRUITING

Cancer Type

Liver Cancer

Interventions

DNAJB1-PRKACA peptide vaccine
Nivolumab
Ipilimumab

Locations (sample)

Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

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…
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 st…
Cohort A and B: Patients \< 18 years old must have a body weight ≥40 kg.

For full eligibility, visit ClinicalTrials.gov.

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