Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Aparajita Singh (ucsf)
Headshot of Aparajita Singh
Aparajita Singh

Description

Summary

This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancers in participants with Lynch syndrome. Each of the three injections in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells. Injecting these substances may cause the immune system to develop a defense against cancer that recognizes and destroys any precancer and cancer cells that produce these proteins in the future. N-803 may increase immune responses to other vaccines. Giving Tri-Ad5 in combination with immune enhancing N-803 may lower the chance of developing colon and other cancers in participants with Lynch syndrome.

Official Title

A Phase IIB Clinical Trial of the Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury) Vaccine (TRI-AD5) and IL-15 Superagonist N-803 in Lynch Syndrome

Details

Keywords

Colorectal Carcinoma, Lynch Syndrome, Colorectal Neoplasms, Hereditary Nonpolyposis Colorectal Neoplasms, Syndrome, Vaccines, Adenovirus 5 CEA/MUC1/Brachyury Vaccine Tri-Ad5, Biopsy, Biospecimen Collection, Colonoscopy, Nogapendekin Alfa, Tri-Ad5, N-803

Eligibility

Locations

  • UCSF Medical Center-Parnassus accepting new patients
    San Francisco California 94143 United States
  • City of Hope Comprehensive Cancer Center not yet accepting patients
    Duarte California 91010 United States
  • Mayo Clinic Hospital in Arizona accepting new patients
    Phoenix Arizona 85054 United States

Lead Scientist at University of California Health

  • Aparajita Singh (ucsf)
    Dr Singh is a board certified gastroenterologist with special interest in colon cancer prevention, high quality colonoscopy. Her other interests include patients with high risk for colon cancer with Lynch Syndrome, FAP and management of patients with a family history of colorectal cancers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT05419011
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 186 study participants
Last Updated