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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Washington
Study ID
NCT05242965
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine — BIOLOGICAL
    Given ID
  • Sargramostim — BIOLOGICAL
    Given ID
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

First listed
Feb 16, 2022
Start date
Mar 24, 2023
Status verified
Jul 2026
Primary completion
Nov 21, 2027
Completion
Nov 21, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (STEMVAC, sargramostim)
    Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
  • Active Comparator: Arm II (sargramostim)
    Patients receive sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.

Primary Outcome Measure

CD8 is Reported as a Fraction of CD3+ Tumor Infiltrating Lymphocytes (TIL) in 4 High-power Field (HPF) [ Time Frame: Baseline and after the third vaccine (at approximately 12 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska98198
Jennifer S Childs, MPH
[email protected]
206-616-2305
Apar Ganti (SUB_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NEFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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