A Phase II Randomized Study of Safety and Efficacy of a Multiple Antigen Vaccine (STEMVAC) in Non-Small-Cell Lung Cancer Patients
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.
• Histologically-confirmed diagnosis of stage IV non-squamous or squamous NSCLC.
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within one month of first vaccine. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Have completed 3-4 cycles of chemoimmunotherapy, without evidence of progressive disease. Pembrolizumab has to be included in at least 3 of these cycles.
• Have not received more than 2 cycles of maintenance pembrolizumab and/or pemetrexed and be a candidate for continuation of this therapy.
• At least 1 site of disease that could be biopsied during treatment. This site should not be a site that is used to determine measurable disease for efficacy purposes. Lesions that will be biopsied should not be on a previously irradiated area unless progression has been demonstrated in such lesions.
• Patients must be at least 28 days post systemic steroids prior to enrollment, unless this is a steroid administered concurrently with chemotherapy or used as part of prophylaxis to prevent intravenous (IV) contrast reactions.
• Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
• Patients must have recovered from major infections and/or surgical procedures, and in the opinion of a principle investigator (PI)/co-PI/study physician/physician extender, not have any significant active concurrent medical illnesses precluding protocol treatment.
• Willing to undergo up to two serial biopsies while on study.
• Estimated life expectancy of more than 6 months.
• White blood cells (WBC) \>= 3000/mm\^3 (within 60 days of first vaccination).
• Lymphocyte count \>= 800/mm\^3 (within 60 days of first vaccination).
• Platelet count \>= 75,000/mm\^3 (within 60 days of first vaccination).
• Hemoglobin (Hgb) \>= 9 g/dl (within 60 days of first vaccination).
• Serum creatinine =\< 1.2 mg/dl or creatinine clearance \> 50 ml/min (within 60 days of first vaccination).
• Total bilirubin =\< 1.5 mg/dl (within 60 days of first vaccination).
• Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) =\< 2 times upper limit of normal (ULN) or SGOT =\< 5 times upper limit of normal (ULN) in the presence of liver metastasis (within 60 days of first vaccination).
• If female of childbearing potential has a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
• All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study.
• Patients must be at least 18 years of age.