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SurVaxM Vaccine for Lung Cancer Prevention

This study is testing a vaccine called SurVaxM to see if it can help prevent lung cancer in people who are at high risk. The SurVaxM vaccine works by training your immune system to fight against cancer cells that have a specific protein called survivin. This could help reduce the growth of tumor cells and lead to their death. You would receive SurVaxM along with two other substances, Montanide ISA 51 VG and Sargramostim, which help the vaccine work better. The main goal is to see how well your body creates an immune response (seroconversion) to the vaccine. This study is for former and current smokers with a significant smoking history and a high risk score for lung cancer. The study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 80 participants.
What's involved
You would receive SurVaxM, Montanide ISA 51 VG, and Sargramostim injections on day 0, week 2, week 4, and week 6, followed by a booster dose at week 18. You will also have blood samples collected throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
After the study treatments, you will be followed up at weeks 20 and 24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07169617

Testing the SurVaxM Vaccine for Lung Cancer Prevention

Not Yet Recruiting
PHASE2Ages 18+InterventionalPrevention
National Cancer Institute (NCI)
~80 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Biospecimen CollectionMontanide ISA 51 VGQuestionnaire AdministrationSargramostimSVN53-67/M57-KLH Peptide Vaccine

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Seroconversion rate
Measured over Up to week 20

Conditions

Lung Carcinoma

Explore related trials

Lung Carcinoma

Where it's being run

4 sites across 4 states
Colorado1
Illinois1
New York1
Tennessee1

Study leadership

  • Saikrishna S Yendamuri · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Robert L. Keith
[email protected]
720-857-5120
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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)
Note: Higher total bilirubin levels (=\< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal
Serum creatinine =\< 1.5 x institutional upper limit of normal
The effects of SurVaxM plus montanide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Ability to understand and the willingness to sign a written informed consent document

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
Prior or current malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (e.g., localized prostate cancer) may be included
History of allergic reactions attributed to compounds of similar chemical or biologic composition to montanide or granulocyte-macrophage colony-stimulating factor (GM-CSF)
Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because of the unknown effects of SurVaxM plus montanide on the fetus. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with SurVaxM plus montanide, breastfeeding should be discontinued if the mother is treated with SurVaxM plus montanide
Individuals participating in another interception trial with an immunomodulatory agent will be excluded from participation in this trial for a washout period of 6 months

What this trial measures

  • Seroconversion rateUp to week 20

    Seroconversion rate will be summarized as the frequency and proportion of participants who achieved sufficient seroconversion, which will be reported with the corresponding 95% confidence intervals. A one-sample exact test for one proportion will be used to test whether seroconversion rate exceeds the unacceptably low rate of 50%.