Vaccination of Advanced-Stage Lung Cancer Patients

Status Withdrawn

Clinical Trial Summary

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial. This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lung Neoplasms

Clinical Trial Details

NCT number	NCT02264236
Study type	Interventional
Source	University of Arkansas
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	October 2015
Completion date	June 2021

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