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 — PROCEDUREUndergo collection of blood samples
- Montanide ISA 51 VG — DRUGGiven SC
- Questionnaire Administration — OTHERAncillary studies
- Sargramostim — BIOLOGICALGiven SC
- SVN53-67/M57-KLH Peptide Vaccine — BIOLOGICALGiven 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | Robert L. Keith (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611 | Seema A. Khan (PRINCIPAL_INVESTIGATOR) |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Saikrishna S. Yendamuri (PRINCIPAL_INVESTIGATOR) |
| University of Tennessee - Knoxville | Knoxville | Tennessee | 37920 | Sean Jordan (PRINCIPAL_INVESTIGATOR) |
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