Study on SurVaxM Vaccine for Preventing Lung Cancer in High-Risk Patients

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07169617

Provider View

This clinical trial is testing a vaccine called SurVaxM to see if it can help prevent lung cancer in people at high risk. The vaccine works by boosting the immune system to attack cancer cells that have a specific protein. It is given with other substances to enhance its effect and increase white blood cells.

Patient Parameters

Program Overview

The purpose of this study is to test how well the SurVaxM vaccine works in preventing lung cancer in people who are at high risk. The vaccine helps the immune system recognize and attack cancer cells that have a protein called survivin. This may help stop cancer cells from growing and lead to their death. SurVaxM is given with montanide, which helps the immune system respond better, and sargramostim, which increases white blood cells. The vaccine may help the body produce antibodies that could prevent lung cancer from developing.

Description

The main goal of this study is to see if the SurVaxM vaccine can create a strong immune response against the survivin protein found in cancer cells.

Secondary goals include:

  • Determining how many participants need a booster dose after three months to achieve a strong immune response.
  • Checking how many participants develop a cellular immune response to the vaccine.
  • Evaluating the safety of the SurVaxM vaccine in this group of people.

Exploratory goals include:

  • Looking at how participants' characteristics relate to their immune response to the vaccine.
  • Studying the relationship between genetic markers and immune responses.

Participants will receive the SurVaxM vaccine with montanide under the skin, followed by sargramostim, on day 0, week 2, week 4, and week 6. A booster dose is given at week 18. Blood samples will be collected throughout the study. After the treatment, participants will have follow-up visits at weeks 20 and 24.

Eligibility Criteria

Inclusion Criteria

  • Former and current smokers with a history of smoking at least 20 pack years.
  • Have a lung cancer risk score greater than 1.34%.
  • Be 18 years or older.
  • Have a performance status that allows for normal daily activities.
  • Have a platelet count of at least 100,000 per microliter.
  • Have normal liver and kidney function as indicated by specific blood tests.
  • Women and men must agree to use effective birth control during the study.
  • Be able to understand and sign a consent form to participate.

Exclusion Criteria

  • Have a history of autoimmune disease requiring immune suppression or organ transplant.
  • Be receiving other cancer treatments or immune-suppressing medications.
  • Have had another cancer unless it was treated successfully and is not expected to interfere with this study.
  • Have allergies to similar compounds used in the study.
  • Have uncontrolled illnesses or psychiatric conditions that would affect participation.
  • Be pregnant or breastfeeding, due to unknown effects on the baby.
  • Be participating in another trial with immune-modulating agents within the last 6 months.

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