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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 52 weeks, and 104 weeks
Awards & highlights
Study Summary
This trial is testing a combination of two vaccines to see if they can prevent cancer in people with Lynch syndrome.
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.Check my eligibility
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.See study design
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.
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I am 18 years old or older.
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I have a genetic condition linked to colon cancer and a history of colon issues.
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I still have part of my lower colon or rectum.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative incidence rate of the composite endpoint of adenomas (tubular, tubulovillous and serrated), advanced adenomas and colon cancer
Secondary outcome measures
Association of clinical factors with immune responses
Incidence of extracolonic neoplasms
Other outcome measures
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 2
~1700
Biopsy
2014
Completed Phase 4
~1090
Colonoscopy
2012
Completed Phase 3
~115560
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,668 Total Patients Enrolled
18 Trials studying Lynch Syndrome
52,880 Patients Enrolled for Lynch Syndrome
Ajay BansalPrincipal InvestigatorUniversity of Kansas
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations have been identified to execute this research in the city?
"The medical trial is currently active at 13 different facilities, including UNC Lineberger Comprehensive Cancer Center in Chapel Hill, Northwestern University in Chicago and the University of Arizona Cancer Center - Prevention Research Clinic in Tucson. Other participating sites are also available."
Answered by AI
What potential risks or hazards are associated with Vaccine Therapy?
"Vaccine Therapy has been assigned a score of 2, as the second phase of trials have only produced data that suggest it is safe but not yet effective."
Answered by AI
Are there any current enrollments for this clinical experiment?
"Per the information hosted on clinicaltrials.gov, this specific trial is no longer accepting participants. Initially published in November of 2022, it was last updated mid-September and has since been closed to recruitment; however, there are over 1300 other studies actively looking for volunteers at present."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic Hospital in Arizona
UNC Lineberger Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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