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Study Summary
This trial studies a cancer vaccine to help prevent recurrence. It will evaluate safety, effectiveness, and dosage.
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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Who is running the clinical trial?
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- My lab results show my organs are not functioning well.I am willing and able to follow the study's requirements.My cancer can be treated with the intention to cure, as per standard care.I am willing to give a tumor tissue and blood sample for testing.I have high blood pressure or heart problems that are not well-managed.I have or had inflammatory bowel disease.I am not on medications that react badly with the study treatment.My cancer is one of the following types and can be removed by surgery: colorectal, head and neck, lung, breast, pancreatic, liver, or melanoma.My treatment followed the recommended guidelines for a cure.I am willing to start treatment with a personalized YE-NEO-001 vaccine.My first check-up after treatment showed no signs of cancer.I have had less than 6 months of standard cancer treatment.I do not have any serious illnesses that would prevent me from taking the study drug.I am 18 years old or older.I haven't taken immunosuppressants for my autoimmune disease in the last 4 weeks.I can take care of myself and am up and about more than half of my waking hours.I agree to give a tumor sample if my cancer comes back during treatment.I can attend all necessary study visits and follow-ups.I can attend all required study visits and follow-ups.I am on daily medication with steroids for a long-term condition.I have had an organ transplant and take medicine to suppress my immune system.
- Group 1: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)
- 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
Are there still vacancies for enrolment in this research study?
"According to clinicaltrials.gov, this medication study is no longer recruiting participants. It was initially listed on August 10th 2018 and the last update occured April 9th 2019; however, there are presently 4012 other trials actively enrolling patients."
Has the Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001) been granted regulatory approval by the FDA?
"Our experts at Power have evaluated Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001) as a 1 on the safety scale, given it is still in Phase 1 and has limited support for both efficacy and protection."
What is the purpose of this experiment?
"This clinical trial, which spans around 19 months, will primarily be assessing the rate of treatment-related side effects. Secondary objectives include Disease-free Survival (DFS), Overall Survival (OS), and Progression-Free Survival (PFS). These metrics are defined as respectively: The time from YE-NEO_001 treatment to disease recurrence or death; time from YE-NEO_001 treatment until death; and the interval between drug administration and progression/death."
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