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Cancer Vaccine for Solid Cancers

Phase 1
Waitlist Available
Research Sponsored by NantBioScience, Inc.
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
Must not have
Inadequate organ function as evidenced by specific laboratory results
Uncontrolled hypertension or clinically significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lab results show my organs are not functioning well.
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I have high blood pressure or heart problems that are not well-managed.
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I have or had inflammatory bowel disease.
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I am not on medications that react badly with the study treatment.
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I do not have any serious illnesses that would prevent me from taking the study drug.
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I can attend all required study visits and follow-ups.
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I am on daily medication with steroids for a long-term condition.
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I have had an organ transplant and take medicine to suppress my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Disease-free survival (DFS)
Overall survival (OS)
Progression-free survival (PFS)
+1 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: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

NantBioScience, Inc.Lead Sponsor
5 Previous Clinical Trials
264 Total Patients Enrolled

Media Library

Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001) Clinical Trial Eligibility Overview. Trial Name: NCT03552718 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)
Non-Small Cell Lung Cancer Clinical Trial 2023: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001) Highlights & Side Effects. Trial Name: NCT03552718 — Phase 1
Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03552718 — Phase 1
~1 spots leftby Jul 2025
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