Lynch Syndrome Vaccine Study

https://www.facingourrisk.org/research-clinical-trials/study/273/testing-a-combination-of-vaccines-for-cancer-prevention-in-lynch-syndrome

Clinicaltrials.gov identifier:
NCT05419011 (https://clinicaltrials.gov/show/NCT05419011)

Prevention
Testing a combination of vaccines for cancer prevention in Lynch syndrome

Study Contact Information:

For more information, please contact ncpc@northwestern.edu

Clinicaltrials.gov identifier: NCT05419011

About the Study

Lynch Syndrome (LS) increases the risk of colon cancer and other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin, and brain.

This study is being done to assess the safety and effectiveness of a series of vaccines (Tri-Ad5), together with another drug (N-803) that magnify the body’s response to vaccines to see if there is an effect on the risk of developing colon and other cancers in LS patients.

For more Information, visit https://bit.ly/ihavelynch

What the Study Entails

If you consent and are eligible to join this trial, you will attend a total of 8 study appointments. During these visits you will receive a series of injections (3-4 injections four times over a one-year period) and undergo yearly colonoscopies as part of routine care. You can also expect physical exams, blood draws, review of your medical history, and completion of questionnaires and a vaccine report card to report any injection side effects.

Study Locations

Site: University of Kansas Medical Center, Kansas City, KS
Protocol and Site Principal Investigator: Ajay Bansal, MD

Site: University of Texas MD Anderson Cancer Center, Houston, TX
Protocol and Site Principal Investigator: Eduardo Vilar-Sanchez, MD, PhD

Site: Northwestern University, Chicago, IL
Investigator: Charles Muller, MD

Site: Cleveland Clinic, Cleveland, OH
Investigator: Carol Burke, MD

Site: University of Puerto Rico, San Juan, Puerto Rico
Investigator: Marcia R. Cruz-Correa, M.D., Ph.D., AGAF, FASGE

Site: Ohio State University, Columbus, OH
Investigator: Peter Stanich, MD

Site: Mayo Clinic Rochester, Rochester, MN
Investigator: Lisa Boardman, MD

Site: Dana-Farber Cancer Institute, Boston, MA
Investigator: Ramona Lim, MD

Site: University of Colorado, Aurora, CO
Investigator: Swati G. Patel, MD, MS

Site: Mayo Clinic at Arizona, Phoenix, AZ
Investigator: Niloy Jewel Samadder, MD, MSc, FRCPC

Site: University of Arizona Cancer Center, Tucson, AZ
Investigator: Aaron James Scott, MD

Site: University of Michigan, Ann Arbor, MI
Investigator: Elena Stoffel, MD, MPH

Site: University of California San Francisco Medical Center
Investigator: Aparajita Singh, MD, MPH

Site: NCI Clinical Center for Research NCICCR
Investigator: Danielle Pastor, DO, PhD

Site: University of Chicago
Investigator: Sonia Kupfer, MD

Site: City of Hope Comprehensive Cancer Center
Investigators: Gregory Idos, MD, MS; Joanne Jeter, MD, MS

Site: Fox Chase Cancer Center
Investigator: Michael J Hall, MD, MS

This Study is Open To:

People 18 years or older who:

Have been diagnosed with Lynch syndrome and have had abnormal growths in their colon or rectum.
Have not had any cancer treatment in the past 6 months.
Are not pregnant or planning to get pregnant.

This Study is Not Open To:

People who do not meet the eligibility criteria defined above and those who:

Have experienced severe side effects or allergic reations to previous vaccines.
Have a blood clotting disorder.
Have had organ transplants.
Are pregnant or breastfeeding.

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.