Tri-Ad5 / ImmunityBio, National Cancer Institute - Bethesda - LARVOL DELTA

Design and preliminary report of a randomized phase IIb clinical trial of multitargeted recombinant adenovirus 5 vaccines against CEA, MUC1, and brachyury (Tri-Ad5) and the IL-15 receptor superagonist nogapendekin alfa inbakicept in Lynch syndrome (TRIAD5-Plus): the first cross-network trial of the Cancer Prevention Clinical Trials Network (CP-CTNet). (PubMed, Front Immunol) - P2 | "In LS carriers without active cancer, the combination of Tri-Ad5 + NAI was well-tolerated; the RCT phase is ongoing. https://clinicaltrials.gov/study/, identifier NCT05419011."

Clinical • Journal • P2b data • Colorectal Cancer • Genetic Disorders • Oncology • Solid Tumor • IL15 • MUC1

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - P2 | N=186 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Colon Cancer • Colorectal Cancer • Genetic Disorders • Oncology • Solid Tumor • EPCAM • MLH1 • MSH2 • MSH6

Tri-Ad5 vaccine plus bintrafusp alfa for newly diagnosed, advanced-stage head and neck cancer not associated with human papillomavirus infection. (PubMed, Oncologist) - P1/2 | "In this small study, Tri-Ad5 vaccine plus bintrafusp alfa resulted in CPD in 2/6 patients. Participants also had favorable 2-year RFS compared to historical values. Ongoing tissue and peripheral immunome analyses may provide mechanistic insight. (ClincalTrials.gov Identifier: NCT04247282; IRB Approved.)."

Journal • Head and Neck Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CEACAM5 • MUC1

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2027 ➔ Jan 2028 | Trial primary completion date: Feb 2027 ➔ Jul 2027

Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Genetic Disorders • Oncology • Solid Tumor • EPCAM • MLH1 • MSH2 • MSH6

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2027 ➔ Feb 2027

Trial completion date • Colon Cancer • Genetic Disorders • Oncology • EPCAM • MLH1 • MSH2 • MSH6

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2027 ➔ Jul 2027

Trial completion date • Colon Cancer • Genetic Disorders • Oncology • EPCAM • MLH1 • MSH2 • MSH6

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: National Cancer Institute (NCI) | Phase classification: P2b ➔ P2

Phase classification • Colon Cancer • Genetic Disorders • Oncology • EPCAM • MLH1 • MSH2 • MSH6

Cancer researchers test preventive vaccine for people with Lynch Syndrome (University of Arizona) - "According to Dr. Scott, Lynch Syndrome study researchers are testing a preventive vaccine series that uses a combination of three vaccines, called Tri-Ad5, combined with a protein, N-803, that boost the body's own immune system to prevent polyps and cancers."

Media quote

National Multicenter Trial Opens to Study ImmunityBio’s Tri-Ad5 Cancer Vaccines Plus N-803 to Prevent Cancer in People with Lynch Syndrome (Businesswire) - "ImmunityBio, Inc...announced the opening of a clinical trial to study its investigational Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803, an immune-enhancer, for people with a hereditary condition known as Lynch syndrome. This Phase 2b trial (NCT05419011) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor