NCT07169617
Testing the SurVaxM Vaccine for Lung Cancer Prevention
Not Yet Recruiting · Phase 2 · National Cancer Institute (NCI) · registry updated 2026-08-26
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. This may result in decreased tumor cell proliferation and lead to tumor cell death. SurVaxM is given with montanide, a substance that helps the immune system respond to the SurVaxM vaccine, followed by sargramostim, which is given to increase the number of white blood cells in the body. The SurVaxM vaccine may help the body make special proteins called antibodies, which may be helpful in preventing the development of lung cancer.
Inclusion
- Former and current smokers (male and female) with a \>= 20 pack year smoking history
- Prostate, Lung, Colorectal and Ovarian (PLCO)m2012 Lung Cancer Risk Prediction Score \> 1.34%
- Participants \>= 18 years old will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of SurVaxM in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%)
- Platelets \>= 100,000/microliter
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
Exclusion
- History of autoimmune disease necessitating systemic immunosuppression, immunodeficiency, and/or organ allograft
- Participants may not be receiving any other chemotherapy (except hormonal agents), immunotherapy or investigational agent, or any immunosuppressive agent, including systemic steroids, including those given after organ transplant
- Participants with current or prior malignancy except for the following:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years before screening and felt to be at low risk for recurrence by treating physician
- Adequately treated carcinoma-in-situ or basal cell carcinoma of the skin without current evidence of disease
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer