NCT07169617

Testing the SurVaxM Vaccine for Lung Cancer Prevention

Evaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the effect of SVN53-67/M57-KLH peptide vaccine (SurVaxM) administration on the generation of a systemic anti-survivin immune response. SECONDARY OBJECTIVES: I. To assess the proportion of participants needing a 3-month booster dose to achieve seroconversion. II. To assess the proportion of participants mounting a cellular immune response to SurVaxM vaccination. III. To assess the safety profile of SurVaxM administration in this population. EXPLORATORY OBJECTIVES: I. To associate participants' demographic and clinical characteristics with outcomes (seroconversion or needing the 3-month booster). II. Correlation of human leukocyte antigen (HLA) typing and the association of HLA types to humoral and/or cellular responses. OUTLINE: Patients receive SurVaxM with montanide ISA 51 VG (montanide) subcutaneously (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. After completion of study intervention, patients are followed up at weeks 20 and 24.

Conditions

• Lung Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
DRUG	Montanide ISA 51 VG	Given SC
OTHER	Questionnaire Administration	Ancillary studies
BIOLOGICAL	Sargramostim	Given SC
BIOLOGICAL	SVN53-67/M57-KLH Peptide Vaccine	Given SC

Timeline

• Start date: 2026-02-25
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2025-09-12
• Last updated: 2026-03-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study