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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically-confirmed cancer amenable to treatment with curative intent as part of SoC
Solid cancers include surgically resectable cancers such as colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer, pancreatic cancer, liver cancer, and melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial studies a cancer vaccine to help prevent recurrence. It will evaluate safety, effectiveness, and dosage.
Who is the study for?
This trial is for adults who've had surgery or other curative treatments for certain solid cancers (like colorectal, breast, lung cancer, etc.) and are now in a surveillance period with no evidence of disease. They must be able to provide tissue samples, have an ECOG status of 0-2, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests YE-NEO-001, a personalized neoepitope yeast-based vaccine designed to trigger T-cell responses against cancer. It's given after standard treatment when patients are monitoring for recurrence. The goal is to find the safest dose and see if it helps prevent cancer from coming back.See study design
What are the potential side effects?
Since this is a phase 1 trial primarily focused on safety and dosage levels, specific side effects aren't listed but may include typical immune-related reactions such as inflammation or flu-like symptoms due to the activation of the body's immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be treated with the intention to cure, as per standard care.
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My cancer is one of the following types and can be removed by surgery: colorectal, head and neck, lung, breast, pancreatic, liver, or melanoma.
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My treatment followed the recommended guidelines for a cure.
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My first check-up after treatment showed no signs of cancer.
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I have had less than 6 months of standard cancer treatment.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I can attend all necessary study visits and follow-ups.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events
Recommended Phase 2 Dose
Secondary outcome measures
Disease-free survival (DFS)
Overall survival (OS)
Progression-free survival (PFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)Experimental Treatment1 Intervention
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Who is running the clinical trial?
NantBioScience, Inc.Lead Sponsor
2 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)
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 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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