STEMVAC Vaccine for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new DNA-based vaccine called STEMVAC, combined with GM-CSF, in patients with advanced lung cancer. The vaccine helps the immune system recognize and attack cancer cells, while GM-CSF boosts this response. The goal is to see if this combination can shrink tumors in these patients. GM-CSF has been used in various tumor vaccines to stimulate the immune system and enhance antitumor responses.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that you should not be on systemic steroids unless they are part of chemotherapy or for preventing IV contrast reactions. It's best to discuss your specific medications with the trial team.
What makes the STEMVAC vaccine treatment unique for lung cancer?
The STEMVAC vaccine is unique because it uses a DNA-based approach to target multiple tumor-associated antigens (proteins that can trigger an immune response) simultaneously, which may enhance the immune system's ability to recognize and attack lung cancer cells. This polyepitope strategy allows for a broader immune response compared to traditional treatments that might target a single antigen.12345
What data supports the effectiveness of the STEMVAC Vaccine for Lung Cancer treatment?
Research shows that SOX-4, one of the components of the STEMVAC vaccine, is overexpressed in lung tumors and can trigger a strong immune response, suggesting its potential as a vaccine target. Additionally, SOX2, another component, has been linked to positive responses in lung cancer patients undergoing immunotherapy, indicating its role in enhancing immune responses against cancer.25678
Who Is on the Research Team?
Shaveta Vinayak
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Rafael Santana-Davila, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
Adults with stage IV non-squamous NSCLC who've completed certain chemotherapy and immunotherapy without disease progression. They must have good organ function, no severe autoimmune diseases or untreated brain metastases, not be pregnant/breastfeeding, and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive STEMVAC and sargramostim intradermally on day 14 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
Follow-up
Participants are monitored for safety and effectiveness after treatment, with blood sample collection and CT scans
What Are the Treatments Tested in This Trial?
Interventions
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
United States Department of Defense
Collaborator