RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Blood draws, CT scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also undergo computed tomography (CT) and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up."
  • "Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up."
  • "After completion of study treatment, patients are followed up twice yearly for up to 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase II study tests whether STEMVAC, a DNA vaccine, can shrink tumors in adults with stage IV non-small cell lung cancer. It is given with GM-CSF, a drug that helps boost the immune response, during ongoing treatment to keep cancer under control. The vaccine aims to help immune cells find and kill lung cancer cells.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with stage IV non-small cell lung cancer confirmed by a tissue test.
  • Have cancer that can be measured within one month before the first vaccine, plus a separate cancer site that can be sampled. Agree to up to two biopsies, which remove small tissue samples.
  • Have finished 3–4 rounds of chemotherapy plus immune treatment without the cancer getting worse. At least 3 rounds must have included pembrolizumab.
  • Have had no more than 2 rounds of ongoing pembrolizumab and/or pemetrexed treatment and be able to continue it.
  • Be fully active or able to do light work. Have recovered from major infections or surgery, have no serious illness that prevents study treatment, and be expected to live more than 6 months.
  • Have stopped steroids that affect the whole body at least 28 days before joining, unless given with chemotherapy or to prevent reactions to scan dye.
  • Meet the study’s blood cell count, kidney, and liver test limits within 60 days before the first vaccine.
  • If able to become pregnant, have a negative pregnancy test within 72 hours before the first dose. Use birth control during the study if having sex that could lead to pregnancy.

Who can't join

  • Have certain serious heart problems, including a stiff heart muscle with symptoms, recent unstable chest pain, severe heart failure being treated, or fluid around the heart causing symptoms.
  • Have untreated cancer spread to the brain or spinal cord. Treated brain cancer spread must be stable for at least 4 weeks, with no new or growing spots, and no steroids for 2 weeks before study dosing.
  • Cannot safely receive GM-CSF products.
  • Have a serious disease in which the immune system attacks the body and need drugs that weaken the immune system. Replacement hormones, such as insulin, do not count; some steroid use is allowed.
  • Have a history of another invasive cancer within 2 years. An exception applies to early-stage cancer treated with the aim of a cure and no return for 2 years since treatment began.
  • Are taking part in another treatment study at the same time.
  • Are pregnant or breastfeeding.
  • Have cancer gene changes with an FDA-approved targeted treatment, unless unable to receive that treatment or the cancer has worsened through those treatments.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Patients with any of the following cardiac conditions: * Symptomatic restrictive cardiomyopathy * Unstable angina within 4 months prior to enrollment * New York Heart Association functional class III-IV heart failure on active treatment * Symptomatic pericardial effusion * Patients with central nervous system (CNS) metastasis that have not been treated. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids for 2 weeks prior to dosing with study medication. * Patients with any contraindication to receiving recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) based products. * Patients with any clinically significant autoimmune disease that requires active treatment with immunosuppressants. Replacement therapy (e.g., thyroxine, insulin) is not considered a form of systemic treatment. Administration of systemic steroids (i.e., for allergic reactions, computed tomography (CT) scans, or the management of immune related adverse events \[irAEs\]) is allowed. * Has a known history of another prior invasive malignancy within 2 years, except subjects with early stage cancer that has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy. * Patients who are simultaneously enrolled in any other treatment study. * Patients who are pregnant or breastfeeding. * Patients with genetic driver alterations (e.g EGFR, ALK, ROS1, BRAF, MET ex 14, RET) for which targeted treatment exist and are Food and Drug Association (FDA) approved, except if the subject is not eligible or has progressed through those therapies.

Study sites (2)

NE

WA