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Cancer Vaccine
Vaccine Nous-209 for Lynch Syndrome
Phase 1 & 2
Recruiting
Led By Eduardo Vilar-Sanchez
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
Participants must have a clinical diagnosis of Lynch syndrome (LS) as defined by specific genetic and clinical criteria
Participants must have no evidence of active or recurrent invasive cancer for 6 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
Study Summary
This trial is testing a vaccine for Lynch syndrome, which is an inherited disorder that causes a higher than normal chance of developing colorectal cancer and certain other types of cancer.
Who is the study for?
This trial is for Lynch syndrome patients without active cancer for 6 months, who can undergo colonoscopy with biopsies yearly. They must be past any cancer treatment by at least 6 months, avoid certain meds, use contraception, and adhere to the study protocol including vaccine cycles and blood sample collection.Check my eligibility
What is being tested?
The Nous-209 vaccine's safety and immune response are being tested in this phase Ib/II trial. It involves biospecimen collection, endoscopic biopsy, two types of vaccines (GAd-209-FSP and MVA-209-FSP), and questionnaire administration to see if it affects polyp or tumor development in the colon.See study design
What are the potential side effects?
Specific side effects aren't listed but may include typical vaccine reactions like discomfort at injection site, fever or fatigue. Participants will be monitored for any high-grade adverse events especially since those with severe reactions from previous cohorts are excluded.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Lynch syndrome based on genetic tests and clinical criteria.
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I have been cancer-free for at least 6 months.
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Doctors can reach my lower colon and rectum with an endoscope.
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I have finished all initial tests and received a full cycle of the vaccine for my group.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of immunogenicity following revaccination (Cohort II)
Rate of immunogenicity following vaccination (Cohort I)
Rates of grade 2/3 adverse events and symptom reactivity following revaccination (Cohort II)
+1 moreSecondary outcome measures
Change in cell free deoxyribonucleic acid (cfDNA) detectability and mutation profile in the peripheral blood
Changes in T cell immune profile and T cell receptor (TCR) repertoire in the peripheral blood
Changes in TCR repertoire within histologically normal colorectal mucosal
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part II Arm B (MVA-209-FSPs)Experimental Treatment4 Interventions
Patients receive MVA-209-FSPs IM at week 52. Patients undergo endoscopy with biopsy as well as blood sample collection on the trial.
Group II: Part II Arm A (GAd20-209-FSPs, MVA-209-FSPs)Experimental Treatment5 Interventions
Patients receive GAd20-209-FSPs IM at week 52 and MVA-209-FSPs IM at week 60. Patients undergo endoscopy with biopsy as well as blood sample collection on the trial.
Group III: Part I (GAd20-209-FSPs, MVA-209-FSPs)Experimental Treatment5 Interventions
Patients receive GAd20-209-FSPs IM on day 1 and MVA-209-FSPs IM at week 8. Patients undergo endoscopy with biopsy during screening and follow up as well as blood sample collection on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,926,072 Total Patients Enrolled
18 Trials studying Lynch Syndrome
53,006 Patients Enrolled for Lynch Syndrome
Eduardo Vilar-SanchezPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
161 Total Patients Enrolled
1 Trials studying Lynch Syndrome
81 Patients Enrolled for Lynch Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Lynch syndrome based on genetic tests and clinical criteria.My biopsy shows high-grade dysplasia or cancer.I have not received a viral vaccine in the last 6 months.I have had an organ transplant or have a condition that weakens my immune system.I agree not to take certain medications during the trial.I do not have an active infection or certain viral infections.I haven't taken steroids or immunosuppressants in the last 14 days.I have been cancer-free for at least 6 months.I agree to take a pregnancy test at week 52.I have given blood samples for research as required for my treatment group.I have an active cancer other than non-melanoma skin cancer.I agree to use birth control during the study.Doctors can reach my lower colon and rectum with an endoscope.I agree to have a colonoscopy with biopsies every year.I have finished all initial tests and received a full cycle of the vaccine for my group.I am willing and able to follow the study's rules and procedures.It has been over 6 months since my last cancer treatment.I had severe side effects in the first part of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Part II Arm A (GAd20-209-FSPs, MVA-209-FSPs)
- Group 2: Part I (GAd20-209-FSPs, MVA-209-FSPs)
- Group 3: Part II Arm B (MVA-209-FSPs)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there still opportunities to join this research endeavor?
"Affirmative, according to clinicaltrials.gov this trial is actively seeking out participants. Initially posted on September 19th 2022 and recently modified on November 22nd 2022, 45 individuals are needed from 3 distinct medical sites."
Answered by AI
What is the current participant count for this research project?
"To ensure the success of this trial, 45 suitable participants are necessary. These candidates must meet specific criteria to be eligible and can join from a variety of locations such as City of Hope Comprehensive Cancer Center or M D Anderson Cancer Center in Houston."
Answered by AI
Could you please elaborate on any prior studies conducted involving the Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP?
"Presently, 16 studies of Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP are underway with none in Phase 3. The bulk of these clinical trials take place in Boston, MA but a total of 75 sites across the globe have been running them."
Answered by AI
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