Vaccine Therapy for Lynch Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic Hospital in Arizona, Phoenix, AZ
Lynch Syndrome+2 More
Vaccine Therapy - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancer 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 cancer in participants with Lynch syndrome.

Eligible Conditions

  • Lynch Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lynch Syndrome

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline, 52 weeks, and 104 weeks

At 104 weeks
Association of clinical factors with immune responses
Cumulative incidence rate of the composite endpoint of adenomas (tubular, tubulovillous and serrated), advanced adenomas and colon cancer
Incidence of extracolonic neoplasms
Week 56
Number of antigen-specific T-cells, peripheral blood mononuclear cells (PBMCs), serum soluble factors and antibody levels
Week 104
Differential expression analyses
Immune cell gene enrichment analysis
Week 104
Prevalence of immune cells markers, tumor associated antigens (TAAs) and stem cell markers

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Lynch Syndrome

Trial Design

6 Treatment Groups

Study phase I (Tri-Ad5)
1 of 6
Safety phase I (Tri-Ad5)
1 of 6
Safety phase II (Tri-Ad5 , N-803)
1 of 6
Study phase II (Tri-Ad5 , N-803)
1 of 6
Arm I (Tri-Ad5, N-803)
1 of 6
Arm II (placebo)
1 of 6
Experimental Treatment
Non-Treatment Group

158 Total Participants · 6 Treatment Groups

Primary Treatment: Vaccine Therapy · Has Placebo Group · Phase 2

Study phase I (Tri-Ad5)Experimental Group · 4 Interventions: Biopsy, Questionnaire Administration, Colonoscopy, Vaccine Therapy · Intervention Types: Procedure, Other, Procedure, Biological
Safety phase I (Tri-Ad5)Experimental Group · 4 Interventions: Biopsy, Questionnaire Administration, Colonoscopy, Vaccine Therapy · Intervention Types: Procedure, Other, Procedure, Biological
Safety phase II (Tri-Ad5 , N-803)Experimental Group · 5 Interventions: Nogapendekin Alfa, Biopsy, Questionnaire Administration, Colonoscopy, Vaccine Therapy · Intervention Types: Drug, Procedure, Other, Procedure, Biological
Study phase II (Tri-Ad5 , N-803)Experimental Group · 5 Interventions: Nogapendekin Alfa, Biopsy, Questionnaire Administration, Colonoscopy, Vaccine Therapy · Intervention Types: Drug, Procedure, Other, Procedure, Biological
Arm I (Tri-Ad5, N-803)Experimental Group · 5 Interventions: Nogapendekin Alfa, Biopsy, Questionnaire Administration, Colonoscopy, Vaccine Therapy · Intervention Types: Drug, Procedure, Other, Procedure, Biological
Arm II (placebo)PlaceboComparator Group · 4 Interventions: Biopsy, Questionnaire Administration, Colonoscopy, Placebo Administration · Intervention Types: Procedure, Other, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Colonoscopy
2012
Completed Phase 3
~33940

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 52 weeks, and 104 weeks
Closest Location: Mayo Clinic Hospital in Arizona · Phoenix, AZ
Photo of Phoenix 1Photo of Phoenix 2Photo of Phoenix 3
2022First Recorded Clinical Trial
2 TrialsResearching Lynch Syndrome
2 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,930 Previous Clinical Trials
41,294,302 Total Patients Enrolled
18 Trials studying Lynch Syndrome
52,688 Patients Enrolled for Lynch Syndrome
Ajay BansalPrincipal InvestigatorNorthwestern University

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
AST/ALT ratio is less than 1.5 x institutional upper limit of normal.
The participants must have at least part of the descending/sigmoid colon and/or rectum intact.
You are at least 6 months from any cancer-directed treatment.
Participants older than 18 years will be enrolled
You have a performance status of 70% or less.
You have leukocytes that are greater than 3,000/microliter.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.