Have you been diagnosed with Lynch Syndrome ?

Lynch Syndrome (LS) increases the risk of colon cancer and can also increase the risk of other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin and brain. Cancer prevention strategies for people with LS are therefore urgently needed. Using vaccines to train the body’s own immune system to prevent polyps and cancers is a new approach that we plan to test in patients with LS.

We are asking you to take part in this research study because you have been diagnosed with Lynch syndrome and your doctor has previously found polyps or cancer in your colon or rectum. This study is being done to find out if we can lower your chance of getting colon cancer and other Lynch cancers by giving you three vaccines, an approach called Tri-Ad5, in combination with an injectable immune-enhancer protein called N-803.

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NWU2015-06-03

Testing a combination of vaccines for cancer prevention in Lynch Syndrome

Principal Investigators:
Ajay Bansal, MD - University of Kansas Medical Center
Eduardo Vilar-Sanchez, MD, PhD - University of Texas MD Anderson Cancer Center

The usual approach for patients with Lynch syndrome is to be followed closely by their doctor with regular colonoscopies, pelvic imaging (ultrasounds), urine tests, computerized tomography scans (CT scans), and skin examinations to watch for the development of cancer. Removal of the colon or uterus before cancer develops is also part of the usual approach. We are doing this study because we want to find out if the vaccines, we are testing will be effective at preventing colon polyps and cancers of the colon and other organs.

The purpose of this study is to compare the safety and effects of the Tri-Ad5 vaccines alone, or in combination with N-803, versus placebo on the risk of developing colon and other cancers in patients with Lynch syndrome. The Tri-Ad5 vaccines and N-803 are not FDA-approved.

More Information: https://clinicaltrials.gov/ct2/show/NCT05419011

This study is no longer enrolling new participants. If you are a current participant and have questions about scheduled visits or updates to your medical history or medications, please contact your study team.