SurVaxM Vaccine for Lung Cancer

Not yet recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Chemotherapy, Immunotherapy, Immunosuppressants, Steroids

Disqualifiers: Autoimmune disease, Immunodeficiency, Organ allograft, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, SurVaxM, to determine its effectiveness in preventing lung cancer in high-risk individuals. The vaccine stimulates the immune system to target cancer cells with a specific protein. Participants will receive the vaccine alongside montanide, which enhances the immune response, and sargramostim, which boosts white blood cell production. Former or current smokers with a history of 20 or more pack years and a high lung cancer risk score may be suitable for the trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot be on other chemotherapy, immunotherapy, or immunosuppressive agents, including systemic steroids. If you're on these, you would need to stop them to participate.

Is there any evidence suggesting that the SurVaxM vaccine is likely to be safe for humans?

Research has shown that the SurVaxM vaccine is generally well-tolerated. In earlier studies, most side effects were mild, such as slight skin reactions at the injection site. No serious side effects were directly linked to the vaccine, suggesting that SurVaxM is quite safe. It is important to note that this information comes from other trials, and the current trial is still assessing its effectiveness in preventing lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for lung cancer?

SurVaxM is unique because it targets the survivin protein, which is often overexpressed in lung cancer cells, helping them avoid cell death. Most standard lung cancer treatments, like chemotherapy and radiation, kill cancer cells but also harm healthy cells, causing significant side effects. SurVaxM, combined with montanide and sargramostim, is designed to stimulate the body's immune response specifically against cancer cells, potentially reducing side effects and improving outcomes. Researchers are excited about SurVaxM because it represents a more targeted immunotherapy approach, which could lead to more effective and less harmful treatment options for lung cancer patients.

What evidence suggests that the SurVaxM vaccine might be an effective treatment for lung cancer?

Research has shown that the SurVaxM vaccine targets a protein called survivin, often found in cancer cells. This vaccine aids the immune system in responding to and attacking these cells. Early results suggest that SurVaxM holds promise in preventing cancer from worsening. In one study, 95.2% of patients did not experience cancer progression six months after treatment. Participants in this trial will receive SurVaxM combined with montanide and sargramostim, which prevent lung cancer from growing and kill cancer cells. These findings offer hope that SurVaxM could be effective for patients at high risk. ^{1 2 6 7 8}

Who Is on the Research Team?

Saikrishna S Yendamuri

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for high-risk patients who may develop lung cancer. It's testing a vaccine called SurVaxM, designed to activate the immune system against cancer cells. Participants should be at risk of lung cancer but currently without it.

Inclusion Criteria

Prostate, Lung, Colorectal and Ovarian (PLCO)m2012 Lung Cancer Risk Prediction Score > 1.34%

Serum creatinine <= 1.5 x institutional upper limit of normal

Platelets >= 100,000/microliter

Exclusion Criteria

History of autoimmune disease necessitating systemic immunosuppression, immunodeficiency, and/or organ allograft

Pregnant or breastfeeding women

History of allergic reactions attributed to compounds of similar composition to montanide or GM-CSF

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SurVaxM with montanide SC followed by sargramostim SC on day 0, week 2, week 4, and week 6

6 weeks

4 visits (in-person)

Booster

Participants receive a booster dose of SurVaxM with montanide SC followed by sargramostim SC on week 18

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SurVaxM

Trial Overview The study examines the effectiveness of SurVaxM, a survivin peptide vaccine, in preventing lung cancer when combined with montanide and sargramostim to boost immune response and white blood cell count.

How Is the Trial Designed?

Group I: Prevention (SurVaxM, montanide, sargramostim) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07169617

Testing the SurVaxM Vaccine for Lung Cancer Prevention This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients.

2. roswellpark.org roswellpark.org/newsroom/202505-roswell-park-announces-positive-progress-clinical-trial-novel-immunotherapy-survaxm

Roswell Park Announces Positive Progress in Clinical ... The clinical trial is designed to evaluate the safety, efficacy and overall survival benefit of SurVaxM in patients with newly diagnosed ...

3. withpower.com withpower.com/trial/phase-2-lung-neoplasms-1-2026-c1834

SurVaxM Vaccine for Lung Cancer · Info for Participants This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00996

Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide ... Of the 63 patients who were evaluable for outcome, 60 (95.2%) remained progression-free 6 months after diagnosis (prespecified primary end point) ...

5. cancernetwork.com cancernetwork.com/view/phase-2b-trial-for-cancer-vaccine-in-newly-diagnosed-glioblastoma-will-continue

Phase 2b Trial for Cancer Vaccine in Newly Diagnosed ... Across 63 evaluable patients, 60 (95.2%) achieved progression-free status at 6 months from diagnosis, and the median PFS was 11.4 months.

6. smartpatients.com smartpatients.com/trials/NCT07169617

Testing the SurVaxM Vaccine for Lung Cancer Prevention Summary. This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients.

7. patlynk.com patlynk.com/trial/NCT07169617

SurVaxM Vaccine for High-Risk Lung Cancer Prevention This study aims to explore how a specific vaccine called SurVaxM can potentially help prevent lung cancer in people who are at a high risk of developing the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5069322/

Clinical study of a survivin long peptide vaccine (SurVaxM) in ... SurVaxM was well tolerated with mostly grade one adverse events (AE) and no serious adverse events (SAE) attributable to the study drug. Six ...