Cancer Prevention Vaccine (Nous-209) for People with Lynch Syndrome

About the Study

This study is testing a vaccine, known as the Nous-209 vaccine, which is intended to decrease the chances that people with Lynch syndrome will develop polyps that can turn into cancer.

People with Lynch syndrome who enroll in the study will participate for one year. It evaluates the safety and effectiveness of the Nous-209 vaccine in people affected with Lynch syndrome.

What the Study Involves

People enrolled in this study will receive a vaccine on day 1 and week 8 of this study. The two vaccines work together to build an immune response (immunity) against colon cancer among people with Lynch syndrome. After the completion of the vaccines, the study will follow up with participants at 16, 24, 36, and 52 weeks.

People enrolled in the study will be asked to complete health questionnaires and have blood tests to determine how their body is responding to the vaccine. Additional procedures such as colonoscopies and endoscopies may be necessary to check the colon for polyps.

Study Sites

Pennsylvania

Philadelphia
Fox Chase Cancer Center   
Contact: Michael J. Hall 215-728-2861 [email protected]

Texas

Houston
MD Anderson Cancer Center 
Contact: Eduardo Vilar-Sanchez 713-563-4743 [email protected]

Puerto Rico

San Juan
University of Puerto Rico 
Contact: Marcia R. Cruz-Correa 787-758-2525 [email protected]

People 18 years of age or older may be eligible if they have or agree to the following:

• Lynch syndrome or Lynch-like syndrome status:
  • Lynch syndrome (LS) with a mutation in one of the following genes: MLH1, MSH2, EPCAM, MSH6, or PMS2, or
  • Lynch-like syndrome who have tested negative for an inherited mutation in a Lynch syndrome gene (or had a result known as a variant of uncertain significance) may be eligible if they have had biomarker testing of a precancer or cancerous tumor that indicates Lynch-like syndrome.
• cancer status:
  • have never been diagnosed with cancer, or
  • those who were previously diagnosed may still be eligible if they:
    • have no evidence of active or recurrent cancer.
    • have received no treatments at least 6 months before enrolling.
• prior surgery:
  • have never had colon surgery, or
  • have had previous colon surgery and have an intact descending/sigmoid colon and/or intact rectum in order to undergo colonoscopy.
• agree to undergo colonoscopy and biopsies every 12 months.
• agree not to use aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase (COX) inhibitors while on the trial, except for low dose aspirin if used to protect their heart health.
• may not receive any vaccines the first 10 weeks of the study and certain vaccines may not be given for the entire year of the study.
• agree to use adequate birth control before and during the study and 6 months after.

People cannot enroll if they:

• are below the age of 18 years old.
• have received certain types of vaccines including COVID19 vaccine within the last 6 months.
• have a current cancer diagnosis.  (except certain types of skin cancer)
• have an autoimmune disorder or history of immunodeficiency.
• have active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infections.
• have a reaction to medications related to the study drug, or to egg proteins.
• are taking steroids or prednisone or other immunosuppressive medications (drugs that prevent your immune system from attacking healthy cells) within 14 days of study drug administration.
• are pregnant, breastfeeding or planning to become pregnant within 6 months after the end of study.
• are attempting or planning to have biological children during the study or within 6 months after the end of the study.
• are not receiving or plan to receive any other study drugs and/or treatments during the enrollment of this study.