Testing the SurVaxM Vaccine for Lung Cancer Prevention

NCT07169617 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: NCI-2025-06377NCI24-19-01NWU24-19-01P30CA060553UG1CA242643
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate

  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%.

  Up to week 20

Secondary Outcomes (6)

• Proportion of participants who require a 3-month booster to achieve seroconversion

  At week 18

• Proportion of participants who achieve seroconversion

  By 3 months

• Proportion of participants who do not achieve seroconversion at 3 months but achieve seroconversion 2-4 weeks after receiving a 3-month booster

  Up to week 20

• Proportion of participants who do not achieve seroconversion

  Up to week 20

• Cellular responses to the administration of SVN53-67/M57-KLH peptide vaccine

  Before the administration of the first dose, 2-4 weeks after completion of the four priming doses, prior to receiving the booster, and 2-4 weeks after completion of the booster

Other Outcomes (2)

• Seroconversion rate

  Up to week 20

• Proportion of participants who require a 3-month booster to achieve seroconversion

  At week 18

Study Arms (1)

Prevention (SurVaxM, montanide, sargramostim)

EXPERIMENTAL

Patients receive SurVaxM with montanide SC followed by sargramostim SC on day 0, week 2, week 4, and week 6. Patients then receive a booster dose of SurVaxM with montanide SC followed by sargramostim SC on week 18. Patients also undergo collection of blood samples throughout the trial.

Procedure: Biospecimen Collection; Drug: Montanide ISA 51 VG; Other: Questionnaire Administration; Biological: Sargramostim; Biological: SVN53-67/M57-KLH Peptide Vaccine

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Prevention (SurVaxM, montanide, sargramostim)

Montanide ISA 51 VG DRUG

Given SC

Prevention (SurVaxM, montanide, sargramostim)

Questionnaire Administration OTHER

Ancillary studies

Prevention (SurVaxM, montanide, sargramostim)

Sargramostim BIOLOGICAL

Given SC

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Prevention (SurVaxM, montanide, sargramostim)

SVN53-67/M57-KLH Peptide Vaccine BIOLOGICAL

Given SC

Also known as: SurVaxM

Prevention (SurVaxM, montanide, sargramostim)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Tennessee - Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Specimen Handling; montanide ISA 51; sargramostim; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Saikrishna S Yendamuri

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 12, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)