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Cancer Vaccine
Personalized Cancer Vaccine + Pembrolizumab for Liver Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Geneos Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving or eligible for first-line therapy with sorafenib or lenvatinib.
18 years of age on day of signing informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new vaccine for liver cancer. The vaccine is made from a person's own tumor cells and is given with another drug, pembrolizumab.
Who is the study for?
Adults with advanced liver cancer (HCC) who haven't had certain treatments, can provide a tissue sample for the vaccine, have an ECOG performance status of 0 or 1, and are expected to live more than 6 months. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with recent encephalopathy, organ transplants, lung disease, active infections like HIV/HBV without treatment plans, or other conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing a personalized neoantigen DNA vaccine (GNOS-PV02), plasmid encoded IL-12 (INO-9012), and pembrolizumab in patients with HCC. It's an open-label Phase I/IIa study where all participants receive this combination therapy to see how well it works against liver cancer.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, flu-like symptoms from IL-12 administration such as fever and fatigue, injection site reactions due to the EP device usage, and typical immunotherapy-related issues like skin rash or digestive problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for or already receiving sorafenib or lenvatinib as my first treatment.
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I am at least 18 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver cancer is at an advanced stage and cannot be cured with local treatments.
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My liver is functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse evets as graded by CTCAE v5.0
Immunogenicity of a personalized neoantigen DNA vaccine as measured by T-cell activation and cytolytic cell phenotype in PBMCs using Flow Cytometry
Immunogenicity of a personalized neoantigen DNA vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Secondary outcome measures
Anti-tumor activity as measured by Disease Control Rate (DCR)
Anti-tumor activity as measured by Duration of Response (DOR)
Anti-tumor activity as measured by ORR by iRECIST
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: GNOS-PV02 + INO-9012 + PembrolizumabExperimental Treatment4 Interventions
First line therapy with standard of care tyrosine kinase inhibitors (TKI) during which patient-specific GNOS-PV02 will be manufactured.
GNOS-PV02 + INO-9012 + Pembrolizumab will be administered upon disease progression or intolerance to TKI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
INO-9012
2014
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Geneos TherapeuticsLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for or already receiving sorafenib or lenvatinib as my first treatment.My doctor thinks this treatment could worsen my other health issues.I am receiving or have received treatment for hepatitis B or C as required.My scans show cancer has spread to my brain or its coverings.I have had treatment for liver cancer, but not with sorafenib or lenvatinib.I have had treatments like immunotherapy or personalized cancer vaccines before.I have had an organ or bone marrow transplant.I have not had brain function issues or taken specific medications for it in the last 6 months.I have a history of lung disease or inflammation not caused by infection.I have not received a live vaccine in the last 30 days.I have been diagnosed with HIV.I have active hepatitis B but plan to receive antiviral therapy.I do not have severe or unstable heart problems.My tumor does not have any genetic mutations.I am at least 18 years old.My liver cancer diagnosis is confirmed by lab tests or imaging, awaiting further confirmation.I am fully active or restricted in physically strenuous activity but can do light work.I am willing to provide a tissue sample for a DNA vaccine.I haven't been in a drug study or used a new medical device in the last 4 weeks and have recovered from any side effects.I have taken sorafenib or lenvatinib in the last 14 days.I have had bleeding from varices in my esophagus or stomach in the last 6 months.I have fluid in my abdomen that's visible on scans.My scans show portal vein invasion, but my lab results meet the study's requirements.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I've had recent liver therapy or surgery but have recovered.I haven't had cancer, except for certain skin, cervical, breast, or early-stage prostate cancers, in the last 5 years.My liver cancer is at an advanced stage and cannot be cured with local treatments.My liver is functioning well.I am currently being treated for an infection.I have confirmed I am not pregnant before starting the treatment.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: GNOS-PV02 + INO-9012 + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other documented cases of GNOS-PV02 being used in a medical capacity?
"GNOS-PV02 was first trialed a decade ago, at City of Hope. In the 10 years since its inception, there have been 256 completed studies. Right now, 1006 trials are recruiting patients with many of them based in Baltimore, Maryland."
Answered by AI
Are participants being enrolled in this trial right now?
"That is accurate. The clinical trial listing on clinicaltrials.gov contains information revealing that the trial is currently looking for subjects. This particular trial was first posted on March 1st, 2020 and updated most recently on April 26th, 2022. From those interested, 36 participants are needed at 2 locations."
Answered by AI
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