RecruitingPhase 1NCT05098210

Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, PD1/PD-L1 Inhibitor-Refractory Melanoma, and Pretreated Non-Small Cell Lung Cancer


Sponsor

Fred Hutchinson Cancer Center

Enrollment

25 participants

Start Date

Jun 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment (refractory) or stage III-IV non-small cell lung cancer. Personalized neo-antigen peptide vaccine is a product that combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine made from your own tumor's unique mutations (called neoantigens), designed to teach your immune system to recognize and attack cancer cells. **You may be eligible if...** - You are 18 years or older - You have a solid tumor (any type) with at least one lesion large enough to biopsy - You have measurable disease that can be tracked on scans - You are in adequate general health (ECOG performance status 0–2) - You are able to provide tumor tissue for analysis to create your custom vaccine **You may NOT be eligible if...** - You have active brain metastases causing symptoms - You have serious autoimmune disease requiring ongoing treatment - You have active uncontrolled infections - Your organ function (liver, kidneys, blood counts) does not meet minimum requirements - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNeoantigen Peptide Vaccine

Given IM

BIOLOGICALNivolumab

Given IV

DRUGPoly ICLC

Given IM

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREPositron Emission Tomography

Undergo PET or PET/CT


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05098210


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