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Cancer Vaccine

Cancer Vaccine + Nivolumab + Ipilimumab for Liver Cancer

Phase 1
Recruiting
Led By Mark Yarchoan, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.
Patients must have adequate liver, kidney and marrow function defined by study-specified laboratory tests prior to initial study drug.
Must not have
Systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration.
Has active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer vaccine in people with a certain type of cancer that has spread or cannot be removed by surgery. The vaccine will be given with two other drugs, and the goal is to see if it is safe and causes T cells to respond.

Who is the study for?
This trial is for individuals with a rare liver cancer called fibrolamellar hepatocellular carcinoma (FLC) that can't be removed by surgery or has spread. Participants must be over 12 years old, weigh at least 40 kg if under 18, and have a tumor that can be biopsied. They need to have good organ function and performance status, not be on certain medications or treatments recently, and agree to use birth control.
What is being tested?
The trial tests the safety of a new vaccine targeting DNAJB1-PRKACA fusion kinase in combination with two immunotherapy drugs: Nivolumab and Ipilimumab. It aims to see how well patients' T-cells respond to this treatment regimen for advanced FLC.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, skin issues, hormone gland problems like thyroid disorders, fatigue, digestive disturbances like diarrhea or colitis, potential lung issues like pneumonitis, liver inflammation known as hepatitis, kidney problems including nephritis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific genetic change known as DNAJB1-PRKACA fusion.
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My liver, kidneys, and bone marrow are functioning well according to specific tests.
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I will use an approved method of birth control during the study.
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I am not pregnant and will follow the birth control guidelines.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I am under 18 and weigh at least 40 kg.
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I am over 18 and have a tumor that can be biopsied.
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My cancer is a type called fibrolamellar and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken high-dose steroids or other immune-weakening drugs in the last week.
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I have an autoimmune disease that needed treatment in the last 2 years.
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I have not had any organ or tissue transplants, including bone marrow.
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I have been diagnosed with an immune system disorder.
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I still have significant side effects from previous treatments.
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I do not have any severe illnesses that my doctors are still trying to get under control.
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I have significant fluid buildup in my abdomen.
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I have had recent issues with diverticulitis, an abscess in my abdomen, or a blockage in my digestive tract.
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I have lung problems that cause me symptoms.
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I do not have active or untreated brain or spinal cord cancer spread.
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My oxygen levels are below 92% without aid or I use supplemental oxygen at home.
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I am infected with HIV or hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fold change in interferon-producing DNAJB1-PRKACA-specific cluster of differentiation 4 (CD4) T cells at 10 weeks
T-Lymphocyte
Number of participants experiencing study drug-related toxicities
Secondary study objectives
Disease control rate (DCR)
Duration of response (DoR)
Objective response rate (ORR)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DNAJB1-PRKACA peptide vaccine, Nivolumab, and IpilimumabExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,015 Total Patients Enrolled
6 Trials studying Liver Cancer
1,439 Patients Enrolled for Liver Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
571 Previous Clinical Trials
33,298 Total Patients Enrolled
3 Trials studying Liver Cancer
144 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,052 Total Patients Enrolled
104 Trials studying Liver Cancer
26,538 Patients Enrolled for Liver Cancer
Fibrolamellar Cancer FoundationUNKNOWN
2 Previous Clinical Trials
27 Total Patients Enrolled
Mark Yarchoan, MDPrincipal InvestigatorJohns Hopkins Medical Institution
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

DNAJB1-PRKACA Fusion Kinase Peptide Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04248569 — Phase 1
Liver Cancer Research Study Groups: DNAJB1-PRKACA peptide vaccine, Nivolumab, and Ipilimumab
Liver Cancer Clinical Trial 2023: DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Highlights & Side Effects. Trial Name: NCT04248569 — Phase 1
DNAJB1-PRKACA Fusion Kinase Peptide Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248569 — Phase 1
~18 spots leftby Mar 2027
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