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Cancer Vaccine + Nivolumab + Ipilimumab for Liver Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't taken high-dose steroids or other immune-weakening drugs in the last week.The doctor will decide if there are any other medical, mental health, or social reasons that make it unsuitable for you to participate in the study.I have been treated with immune system boosting drugs for my cancer.I have an autoimmune disease that needed treatment in the last 2 years.My cancer has a specific genetic change known as DNAJB1-PRKACA fusion.I have not had any organ or tissue transplants, including bone marrow.My cancer is advanced, cannot be surgically removed, and tests positive for a specific genetic change.My liver, kidneys, and bone marrow are functioning well according to specific tests.I will use an approved method of birth control during the study.I have been diagnosed with an immune system disorder.I still have significant side effects from previous treatments.You have had an allergic reaction to any type of antibody medication.I do not have any severe illnesses that my doctors are still trying to get under control.I haven't had cancer treatment like chemo, biological therapy, or radiation in the last 14 days.I am not pregnant and will follow the birth control guidelines.I am older than 12 years.I am 18 years old or older.I have significant fluid buildup in my abdomen.I have had recent issues with diverticulitis, an abscess in my abdomen, or a blockage in my digestive tract.I have lung problems that cause me symptoms.I can take care of myself but might not be able to do heavy physical work.I do not have active or untreated brain or spinal cord cancer spread.You have had allergic reactions or known sensitivity to the experimental drug(s).My oxygen levels are below 92% without aid or I use supplemental oxygen at home.I had a severe reaction to previous immune therapy.I am under 18 and weigh at least 40 kg.I am willing and able to follow the study schedule.I am over 18 and have a tumor that can be biopsied.I have not had a live vaccine for infectious diseases in the last 28 days.I am infected with HIV or hepatitis B or C.My cancer is a type called fibrolamellar and cannot be removed by surgery.You cannot be using illegal drugs or abusing other substances.I haven't had major surgery in the last 28 days, except for minor procedures or specific treatments.
- Group 1: DNAJB1-PRKACA peptide vaccine, Nivolumab, and Ipilimumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What conditions has the DNAJB1-PRKACA peptide vaccine been demonstrated to address?
"DNAJB1-PRKACA peptide vaccine is a proven anti-angiogenic therapy. It has also been used to treat malignant neoplasms, unresectable melanoma, and squamous cell carcinoma with varying degrees of efficacy."
Has the DNAJB1-PRKACA peptide vaccine been granted official approval by the FDA?
"As this DNAJB1-PRKACA peptide vaccine is still in its first trial phase, the safety rating for it falls at a score of 1 due to limited prior efficacy and security data."
What aims does this research endeavor hope to accomplish?
"This clinical trial, monitored over a Baseline and 10 week period, will evaluate the prevalence of study drug-related toxicities. Secondary objectives involve estimating overall survival through Kaplan-Meier curves as well as iRECIST Objective Response Rate (iRORR), which is determined by amount of complete or partial response to treatment per RECIST 1.1 guidelines, and Duration of Response (DoR) defined by weeks from start date of PR/CR until disease progression or death on record."
Are there any openings available for enrollees in this research project?
"Affirmative. Evidence available on clinicaltrials.gov affirms the recruitment of participants for this investigation, which was first declared on April 21st 2020 and revised recently on March 3rd 2022. Currently, 12 volunteers are needed across 1 medical centre."
What is the total size of the patient cohort involved in this clinical experiment?
"Affirmative, according to the latest information on clinicaltrials.gov this medical trial is currently enrolling patients. The initial advertisement for enrolment was posted on April 21st 2020 and it has been revised as recently as March 3rd 2022. 12 participants are being sought from a single medical centre."
Has the efficacy of a DNAJB1-PRKACA peptide vaccine been examined in any earlier studies?
"Presently, there are 764 active clinical trials researching a DNAJB1-PRKACA peptide vaccine. Of these studies, 86 have reached the Phase 3 stage of testing. Most research is based in Pittsburgh, Pennsylvania but over 42000 other locations around the world are conducting experiments with this drug."
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