NCT02264236

Vaccination of Advanced-Stage Lung Cancer Patients

"Vaccination of Advanced-Stage Lung Cancer Patients" A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	P10s-PADRE vaccine	P10s-PADRE vaccine combined with MONTANIDE™ ISA 51 VG "Chemotherapy" Subcutaneous injection at weeks 2, 3, 5, and 6. "3-Week Interval Immunotherapy" Subcutaneous injection at weeks 2, 3, and 4. "2-Week Interval Immunotherapy" Subcutaneous injection at weeks 3, 4, and 5.

Timeline

• Start date: 2015-10-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2014-10-15
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study