Basket Trial of Neoantigen Synthetic Long Peptide Vaccines in Patients With Advanced Malignancy

Study Overview
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Brief Summary
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This is a basket trial of neoantigen synthetic long peptide vaccines in patients with advanced malignancy. Up to 20 subjects will be treated with the neoantigen synthetic long peptide vaccines.

Detailed Description
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This is a basket trial of neoantigen synthetic long peptide vaccines in patients with advanced malignancy. Up to 20 subjects will be treated with the neoantigen synthetic long peptide vaccines. To determine the safety of neoantigen synthetic peptide vaccines. To assess the immune response to neoantigen synthetic long peptide vaccines as measured by ELISPOT. Neoantigen synthetic long peptide vaccines are composed of synthetic long peptides which are 25-30 amino acids in length and designed to induce immune responses to cancer neoantigens identified by exome sequencing. Neoantigen synthetic long peptide vaccines will be co-administered with poly-ICLC, an innate immune adjuvant capable of activating TLR3 and other pathways.

Official Title
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Basket Trial of Neoantigen Synthetic Long Peptide Vaccines in Patients With Advanced Malignancy

Conditions
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Cancer, Solid Tumor

Intervention / Treatment
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* Biological: Personalized Synthetic Long Peptide Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients with advanced malignancies and limited treatment options with an estimated 5 year survival of less than 50%. Patient must have advanced solid tumors that have progressed after treatment with standard FDA approved therapies, or for which no effective standard therapy is available, or the subject has a contraindication to standard therapy. Other Inclusion Criteria: 1. >= 18 years of age. 2. ECOG performance status ≤ 2 3. Adequate organ function allowing favorable benefit to risk ratio per the treating physician 4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration. 5. Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: 1. History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine. 2. Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies). 3. Psychiatric illness or social situations that would limit compliance with study requirements. 4. History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine. 5. Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test. 6. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized. 7. Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Synthetic Long Peptide Vaccine<br> | Biological: Personalized Synthetic Long Peptide Vaccine<br>* Personalized Synthetic Long Peptide Vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of neoantigen synthetic peptide vaccines by rate of serious safety events by CTCAE v5. | The primary objective is to determine the rate of serious safety events | 5 years | 
| To assess the immune response to neoantigen synthetic long peptide vaccines as measured by percent of patients with ELISPOT positive response | The secondary outcome is to determine the percent of patients showing an immune response to the vaccine components | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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personalized neoantigen vaccine