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

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.

NCT Number	NCT05098210
Lead Sponsor	Fred Hutchinson Cancer Center Collaborators: Amazon, Inc.
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 +17 more
Enrollment	28 participants
Start Date	2022-06-09
Primary Completion	2027-11-01 (estimated)
Study Completion	2028-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-22