Testing a Combination of Vaccines to Prevent Cancer in People with Lynch Syndrome

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05419011

Provider View

This study is exploring whether a combination of vaccines, Tri-Ad5 and N-803, can help prevent colon and other cancers in people with Lynch syndrome. The vaccines aim to train the immune system to recognize and destroy cancer cells before they develop.

Patient Parameters

Program Overview

This clinical trial is testing a new approach to prevent cancer in people with Lynch syndrome, a genetic condition that increases the risk of colon and other cancers. The study uses a combination of vaccines: Tri-Ad5, which contains substances found in cancer cells, and N-803, which boosts the immune response. The goal is to see if these vaccines can help the immune system recognize and attack cancer cells, reducing the risk of developing cancer in the future.

Description

The main goal of this study is to see if the combination of Tri-Ad5 vaccines and N-803 can lower the chances of developing colorectal cancer in people with Lynch syndrome. Researchers will also look at how safe and tolerable these vaccines are when used together.

The study will also explore how lifestyle factors like aspirin use, smoking, and alcohol intake might affect the immune response to the vaccines. Additionally, the study will assess the impact of the vaccines on other types of cancers related to Lynch syndrome and evaluate participants' experiences with the vaccines, including any stress related to cancer and overall quality of life.

Researchers will also investigate how the vaccines affect the immune system over time, looking at both early and long-term immune responses. They will measure specific immune markers and changes in the immune cells in the colon after vaccination.

Participants will receive the vaccines at specific intervals and undergo regular colonoscopies to monitor for any changes in their health. Blood samples will be collected throughout the study to assess the immune response.

Eligibility Criteria

Inclusion Criteria

  • Have Lynch syndrome, confirmed by genetic testing, with a history of certain types of colon polyps or cancer, but no active cancer for at least 6 months.
  • Must have part of the colon or rectum intact.
  • At least 6 months since any cancer treatment like surgery, chemotherapy, or radiation.
  • Be 18 years or older, as the risk of cancer is low in younger individuals.
  • Be in good overall health, with specific blood counts and organ function within normal limits.
  • Women and men must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form.
  • Must space COVID vaccines at least 2 weeks before and after receiving the study vaccines.

Exclusion Criteria

  • History of organ transplant or immune system disorders.
  • Active HIV, hepatitis B, or hepatitis C infections, unless cleared.
  • Use of high-dose steroids or other immune-suppressing drugs recently.
  • Participation in other experimental treatments.
  • Allergies to similar vaccines or N-803.
  • Uncontrolled health or mental health issues that affect study participation.
  • Pregnant or breastfeeding women, due to unknown risks to the baby.
  • History of untreated blood clotting disorders.
  • Severe reactions to previous adenovirus-based vaccines.
  • History of atrial fibrillation.

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