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

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Locally Advanced Cutaneous Melanoma
• Locally Advanced Mucosal Melanoma
• Metastatic Acral Melanoma
• Metastatic Conjunctival Melanoma
• Metastatic Cutaneous Melanoma
• Metastatic HER2-Negative Breast Carcinoma
• Metastatic Hormone Receptor-Positive Breast Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Mucosal Melanoma
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IIID Cutaneous Melanoma AJCC v8
• Recurrent Cutaneous Melanoma
• Recurrent HER2-Negative Breast Carcinoma
• Recurrent Hormone Receptor-Positive Breast Carcinoma
• Recurrent Lung Non-Small Cell Carcinoma
• Recurrent Mucosal Melanoma
• Stage III Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Unresectable Acral Melanoma
• Unresectable Cutaneous Melanoma
• Unresectable Lung Non-Small Cell Carcinoma
• Unresectable Mucosal Melanoma

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

Sponsors & Collaborators

• Amazon, Inc.

  collaborator INDUSTRY

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Joshua Veatch · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-09

Primary Completion

2027-11-01

Completion

2028-11-01

FDA Drug

Yes

Countries

• United States

Study Locations