Testing the SurVaxM Vaccine for Lung Cancer Prevention

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07169617
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Mar 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prevention (SurVaxM, montanide, sargramostim)
    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.

Primary Outcome Measure

Seroconversion rate [ Time Frame: Up to week 20 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Rocky Mountain Regional VA Medical CenterAuroraColorado80045
Robert L. Keith
720-857-5120
Robert L. Keith (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Seema A. Khan
312-503-4236
Seema A. Khan (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
Saikrishna S. Yendamuri
716-845-1228
Saikrishna S. Yendamuri (PRINCIPAL_INVESTIGATOR)
University of Tennessee - KnoxvilleKnoxvilleTennessee37920
Sean Jordan
865-305-6955
Sean Jordan (PRINCIPAL_INVESTIGATOR)

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