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.
- 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:
- SECONDARY ID:
- NCT ID:
|P10s-PADRE vaccine||Mimotope P10s-PADRE Vaccine||P10s-PADRE vaccine|
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.
|P10s-PADRE vaccine||Active Comparator||Subjects 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.|
|Placebo||Placebo Comparator||Subjects will receive placebo.|
- stage IV Non-Small Cell Lung Cancer
- completed their primary chemotherapy
- achieved either stable disease or partial response with measurable residual disease
- Women who are pregnant or breast-feeding.
- Patients who have autoimmune disease or are immunosuppressed or receiving systemic
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|
Primary Outcome Measures
|Measure:||Number of participants with sufficient tumor response rate|
|Time Frame:||12 months|
|Lead Sponsor:||University of Arkansas|
January 4, 2017