drugset
drugset / Trial / NCT05098210

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

NCT05098210 ↗

Phase 1 Recruiting 25 enrolled Fred Hutchinson Cancer Center Amazon, Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-09
Primary completion
2027-11-01
Completion
2028-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Neoantigen Peptide Vaccine Vaccine — —
Background Hiltonol Other / unclassified — Intramuscular
Background Nivolumab Monoclonal antibody — Intravenous

Indications

acral lentiginous melanoma female breast carcinoma hormone receptor-positive breast cancer malignant conjunctival melanoma metastatic malignant neoplasm mucosal melanoma non-small cell lung carcinoma