Clinical Trials /

Vaccination of Advanced-Stage Lung Cancer Patients

NCT02264236

Description:

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.

Related Conditions:
  • Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vaccination of Stage IV NSCLC Patients With a Carbohydrate Mimotope Vaccine
  • Official Title: Vaccination of Stage IV NSCLC Patients With a Carbohydrate Mimotope Vaccine

Clinical Trial IDs

  • ORG STUDY ID: 203199
  • SECONDARY ID: 203199
  • NCT ID: NCT02264236

Conditions

  • Lung Neoplasms

Interventions

DrugSynonymsArms
P10s-PADRE vaccineMimotope P10s-PADRE VaccineP10s-PADRE vaccine
PlaceboPlacebo

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.

Trial Arms

NameTypeDescriptionInterventions
P10s-PADRE vaccineActive ComparatorSubjects will be immunized by administration of four doses of P10s-PADRE vaccine over an eight-week period at a dose level of 500 micrograms (µg) per injection.
    PlaceboPlacebo ComparatorSubjects will receive placebo.

      Eligibility 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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Number of participants with sufficient tumor response rate
      Time Frame:12 months
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:University of Arkansas

      Last Updated

      January 4, 2017