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 magnifies 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.