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

Recruiting Phase 1 Interventional Study
Fibrolamellar Hepatocellular Carcinoma (FLC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
56 (estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
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About This Trial

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 Locations
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Eligibility Criteria
Inclusion Criteria for Cohort A, B and C: * 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 tumo…
Contacts

Colleen Apostol, RN

410-614-3644

GIClinicalTrials@jhmi.edu

CONTACT

Marina Baretti, MD

410-614-1058

mbarett1@jhu.edu

CONTACT