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RECRUITING
NCT05098210
PHASE1

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

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2022-06-09

Completion Date

2028-11-01

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Neoantigen Peptide Vaccine

Given IM

BIOLOGICAL

Nivolumab

Given IV

DRUG

Poly ICLC

Given IM

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET or PET/CT

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States