Little Rock, Arkansas 72205


Purpose:

The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in patients of all races with stage IV Non-Small Cell Lung Cancer who have completed their primary chemotherapy without progressing, and who still have measurable residual disease. A randomized double-blind placebo-controlled trial is designed with the goal being to evaluate the efficacy of the vaccine. Efficacy will be based primarily on the tumor response, and secondarily on progression-free survival. Information on safety and tolerability will be collected. Humoral and cellular immune responses will be analyzed.


Criteria:

Inclusion Criteria: - stage IV Non-Small Cell Lung Cancer - completed their primary chemotherapy - achieved either stable disease or partial response with measurable residual disease Exclusion Criteria: - Women who are pregnant or breast-feeding. - Patients who have autoimmune disease or are immunosuppressed or receiving systemic corticosteroids


NCT ID:

NCT02264236


Primary Contact:

Principal Investigator
Konstantinos Arnaoutakis, MD
University of Arkansas

Konstantinos Arnaoutakis, MD
Email: Karnaoutakis@uams.edu


Backup Contact:

N/A


Location Contact:

Little Rock, Arkansas 72205
United States

Konstantinos Arnaoutakis, MD
Email: karnaoutakis@uams.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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