Actively Recruiting

Phase 1
Age: 12Years +
All Genders
NCT04248569

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-12-03

56

Participants Needed

1

Research Sites

723 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

F

Fibrolamellar Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cohort A and B: Histologically confirmed metastatic or unresectable fibrolamellar hepatocellular carcinoma (FLC)
  • Cohort C: Histologically proven metastatic or unresectable DNAJB1-PRKACA fusion transcript positive non-FLC solid tumors
  • Cohort A and B: Age greater than 12 years; patients under 18 must weigh at least 40 kg
  • Cohort C: Age 18 years or older
  • All cohorts: Presence of DNAJB1-PRKACA fusion transcript confirmed by RNA or DNA sequencing or in situ hybridization
  • ECOG performance status of 2 or lower (Karnofsky score 60% or higher)
  • Adequate liver, kidney, and bone marrow function as defined by laboratory tests
  • Measurable disease according to RECIST 1.1 criteria
  • Willingness to provide tissue and blood samples for mandatory translational research
  • Women of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines
  • Men must use an acceptable form of birth control
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Cohort A and C: Prior treatment with checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or similar antibodies (interferon-alpha allowed)
  • Cohort B: History of life-threatening toxicity from prior immune therapy except manageable conditions
  • Chemotherapy, biological therapy, or radiation within 14 days before first study drug dose
  • Surgery within 28 days before first study drug dose, except minor procedures
  • Use of other approved or investigational agents or devices within 28 days before first study drug dose
  • Unrecovered acute adverse events from prior treatments except alopecia or stable neuropathy
  • Use of non-oncology live vaccines within 28 days before study treatment
  • Known allergic reactions or sensitivity to study drugs or monoclonal antibodies
  • Active autoimmune disease requiring systemic treatment in past 2 years or severe autoimmune history
  • Presence of tissue or organ allograft or history of stem cell transplant
  • Diagnosis of immunodeficiency
  • Systemic corticosteroids over 10 mg prednisone equivalent or immunosuppressants within 7 days before study drug
  • Symptomatic interstitial lung disease
  • Oxygen saturation below 92% on room air or need for home oxygen
  • Active or untreated brain or leptomeningeal metastases
  • Uncontrolled illnesses such as infections, heart failure, arrhythmias, metastatic cancer, or psychiatric/social issues
  • Pregnant or breastfeeding
  • Infection with HIV or hepatitis B or C
  • Active or acute diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction
  • Inability or unwillingness to follow the study schedule
  • Any other medical, psychiatric, or social reasons as judged by the investigator
  • Illicit drug or substance abuse
  • Clinically meaningful ascites

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

C

Colleen Apostol, RN

CONTACT

M

Marina Baretti, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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