RecruitingPhase 2NCT05242965

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer

A Phase II Randomized Study of Safety and Efficacy of a Multiple Antigen Vaccine (STEMVAC) in Non-Small-Cell Lung Cancer Patients


Sponsor

University of Washington

Enrollment

40 participants

Start Date

Mar 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests whether CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine (STEMVAC) works to shrink tumors in patients with stage IV non-small cell lung cancer. STEMVAC targets specific immunogenic proteins that help lung cancer cells to grow. STEMVAC is made up of deoxyribonucleic acid (DNA), which is a natural substance in every living organism. DNA acts like a blueprint that tells all the cells in your body how to function. The DNA used in this study contains instructions for your body to produce parts of the 5 proteins the investigators identified (CDH3, CD105, YB-1, MDM2 and SOX2). STEMVAC is given with granulocyte-macrophage colony stimulating factor (GM-CSF) which is being used as an adjuvant to help create a stronger immune response. Giving STEMVAC with GM-CSF to patients while on maintenance therapy for non-small cell lung cancer (NSCLC) may help activate certain immune cells to recognize and kill lung cancer cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biopsy, a procedure called Biospecimen Collection, and others for people with lung non-small cell carcinoma and stage iv lung cancer ajcc v8. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Given ID

BIOLOGICALSargramostim

Given ID

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(2)

University of Nebraska Medical Center

Omaha, Nebraska, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05242965


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