Your session is about to expire
← Back to Search
Cancer Vaccine
Cancer Vaccines for Lynch Syndrome
Phase 2
Recruiting
Led By Ajay Bansal
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Participants must be >= 18 years old
Must not have
History of organ allograft or other history of immunodeficiency
Known HIV with CD4 count < 540, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 52 weeks, and 104 weeks
Summary
This trial tests a vaccine and an immune booster to prevent cancer in people with Lynch syndrome. The vaccine teaches the body to fight cancer, and the booster makes this process stronger. Vaccines have shown robust potential for preventing Lynch syndrome cancers.
Who is the study for?
This trial is for adults with Lynch syndrome who've had adenomas, advanced adenomas, or colon cancer. They must be at least 6 months post any cancer treatment and have part of their colon/rectum intact. Participants need normal blood counts and organ function tests, agree to contraception use, and space out COVID vaccines around the study timeline. Exclusions include untreated blood clots, recent immunosuppressants use, certain infections like HIV/HBV/HCV with specific conditions, pregnancy/breastfeeding women, history of severe vaccine allergies.
What is being tested?
The trial is testing a combination of Tri-Ad5 vaccine (with three substances targeting precancer/cancer cells) and N-803 (an immune enhancer), aiming to prevent cancers in those with Lynch syndrome. The idea is that this combo might train the immune system to fight off potential cancer cells more effectively.
What are the potential side effects?
Potential side effects may include typical reactions from vaccinations such as soreness at injection site or fever. Since it involves stimulating the immune system there's also a risk of autoimmune responses or allergic reactions especially for those with a history related to similar vaccines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly active and can care for myself.
Select...
I am 18 years old or older.
Select...
I have a genetic condition linked to colon cancer and a history of colon issues.
Select...
I still have part of my lower colon or rectum.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had an organ transplant or have a condition that weakens my immune system.
Select...
I have HIV with a CD4 count under 540, or I have hepatitis B or C.
Select...
I have a history of blood clots that haven't been treated.
Select...
I haven't taken steroids or immunosuppressants in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 52 weeks, and 104 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 52 weeks, and 104 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative incidence rate of the composite endpoint of adenomas (tubular, tubulovillous and serrated), advanced adenomas and colon cancer
Secondary study objectives
Association of clinical factors with immune responses
Incidence of extracolonic neoplasms
Other study objectives
Differential expression analyses
Immune cell gene enrichment analysis
Number of antigen-specific T-cells, peripheral blood mononuclear cells (PBMCs), serum soluble factors and antibody levels
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Safety phase II (Tri-Ad5 , N-803)Experimental Treatment6 Interventions
Participants receive Tri-Ad5 SC and N-803 SC at weeks 0, 4, 8, and 52. Participants also undergo SOC colonoscopy with biopsy at baseline and at 52 weeks and 104 weeks. Participants undergo blood sample collection throughout the study.
Group II: Safety phase I (Tri-Ad5)Experimental Treatment5 Interventions
Participants receive Tri-Ad5 SC at weeks 0, 4, 8, and 52. Participants also undergo SOC colonoscopy with biopsy at baseline and at 52 weeks and 104 weeks. Participants undergo blood sample collection throughout the study.
Group III: Arm I (Tri-Ad5, N-803)Experimental Treatment6 Interventions
Participants receive Tri-Ad5 SC and N-803 SC at weeks 0, 4, 8, and 52. Participants also undergo SOC colonoscopy with biopsy at baseline and at 52 and 104 weeks. Participants undergo blood sample collection throughout the study.
Group IV: Arm II (placebo)Placebo Group5 Interventions
Participants receive placebo SC at weeks 0, 4, 8, and 52. Participants also undergo SOC colonoscopy with biopsy at baseline and at 52 and 104 weeks. Participants undergo blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Biopsy
2014
Completed Phase 4
~1150
Colonoscopy
2012
Completed Phase 3
~115560
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lynch Syndrome treatments often focus on immunotherapy to harness the body's immune system against cancer cells. The Tri-Ad5 vaccine introduces substances from precancerous and cancerous cells to stimulate an immune response, teaching the immune system to target these cells.
N-803 enhances this effect by boosting the immune response to the vaccine. This approach aims to provide a strong defense against cancer development in Lynch Syndrome patients, potentially lowering their cancer risk.
Immunotherapy in Pancreatic Cancer: Why Do We Keep Failing? A Focus on Tumor Immune Microenvironment, Predictive Biomarkers and Treatment Outcomes.Advances in Immunotherapies for Gliomas.Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors: A phase I clinical trial.
Immunotherapy in Pancreatic Cancer: Why Do We Keep Failing? A Focus on Tumor Immune Microenvironment, Predictive Biomarkers and Treatment Outcomes.Advances in Immunotherapies for Gliomas.Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors: A phase I clinical trial.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,394 Total Patients Enrolled
Ajay BansalPrincipal InvestigatorUniversity of Kansas
1 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ transplant or have a condition that weakens my immune system.I have HIV with a CD4 count under 540, or I have hepatitis B or C.Your creatinine levels are within the normal range set by the hospital.You have a white blood cell count of at least 3,000 per microliter.It has been over 6 months since my last cancer treatment.I can schedule my COVID vaccines around the study treatment by 2 weeks.It has been over 6 months since my last cancer treatment.I have a history of blood clots that haven't been treated.Your platelet count is at least 100,000 per microliter.Your bilirubin levels are within the normal range for the hospital.Your AST and ALT liver enzyme levels are not higher than 1.5 times the normal limit.Your liver function tests should not be more than 1.5 times the normal level.I haven't taken steroids or immunosuppressants in the last 3 months.You need to have a certain level of white blood cells called neutrophils in your blood.I am mostly active and can care for myself.I am 18 years old or older.You have had allergic reactions to vaccines similar to adenovirus-based vaccines and N-803.You had bad reactions to vaccines made from adenovirus in the past.People with Lynch syndrome as determined by specific criteria.I agree to use birth control during the study.I have a genetic condition linked to colon cancer and a history of colon issues.I still have part of my lower colon or rectum.
Research Study Groups:
This trial has the following groups:- Group 1: Safety phase I (Tri-Ad5)
- Group 2: Safety phase II (Tri-Ad5 , N-803)
- Group 3: Arm I (Tri-Ad5, N-803)
- Group 4: Arm II (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.