What side effects are associated with this type of intervention?

Common side effects of treatments for Lynch Syndrome that stimulate the immune response against neoantigens, such as the Nous-209 vaccine, include injection site reactions, fever, fatigue, and muscle aches. More severe but less common side effects can involve autoimmune reactions, potentially causing colitis, hepatitis, or endocrinopathies. These side effects are typically manageable with medical intervention.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Lynch Syndrome that focus on stimulating an immune response against neoantigens similar to the Nous-209 vaccine. Lynch Syndrome management primarily involves regular surveillance and preventive measures to reduce cancer risk. Immunotherapy approaches, such as vaccines targeting neoantigens, are still under investigation in clinical trials.

What other types of research exist?

Promising novel alternatives to the Nous-209 vaccine for Lynch Syndrome patients may include checkpoint inhibitors like pembrolizumab or nivolumab, which have shown efficacy in cancers with high microsatellite instability (MSI-H) or mismatch repair deficiency (MMR-D). Additionally, other neoantigen-based vaccines or personalized cancer vaccines targeting specific mutations in Lynch Syndrome could be considered.

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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

Must not have

Histologically-confirmed high-grade dysplasia or cancer on biopsy at screening

History of organ allograft or other history of immunodeficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

Summary

This trial tests the safety and effectiveness of the Nous-209 vaccine in patients with Lynch syndrome, a condition that increases cancer risk. The vaccine uses man-made proteins to help the immune system recognize and fight cancer cells. Researchers aim to see if the vaccine can prevent cancer development in these high-risk patients. Nous-209 is a ready-to-use cancer vaccine that targets specific markers found in certain types of tumors.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My biopsy shows high-grade dysplasia or cancer.

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I have had an organ transplant or have a condition that weakens my immune system.

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I do not have an active infection or certain viral infections.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I have an active cancer other than non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of immunogenicity following revaccination (Cohort II)

Rate of immunogenicity following vaccination (Cohort I)

Secondary study objectives

Immune response to Nous-209

Mismatch repair and/or microsatellite instability status of polyps (and adjacent normal mucosa as control)

Percentage change in the number of colorectal adenomas, advanced neoplasia, and/or carcinomas

Trial 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 3

~2020

0 / 9Eligibility criteria met

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 enhancing the immune system's ability to recognize and destroy cancer cells. The Nous-209 vaccine, for example, uses synthetic copies of neoantigens produced by cancer cells due to DNA mismatch repair deficiencies. By stimulating an immune response against these neoantigens, the vaccine helps the body identify and eliminate cancerous cells more effectively. This targeted approach is significant for Lynch Syndrome patients as it offers a potential method to prevent cancer development by leveraging the body's natural immune defenses.

Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.[Molecule based diagnosis].Relevance of the immune system in human urological malignancies: prospective for future clinical treatments.