NCT01949701

Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*02 Disease Controlled Advanced Non-small Cell Lung Cancer

Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 (URLC10) in Patients With Disease Controlled Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Shiga University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators previously identified a novel HLA-A\*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung cancer. In this clinical study, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

Detailed description

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*0201 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers. The investigators previously identified a novel HLA-A\*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies, but who do not have any options for additional standard ones to prevent .future relapse of the disease.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HLA-A*0201restricted URLC10 peptides with adjuvant	Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A\*0201restricted URLC10 peptides with adjuvant.

Timeline

• Start date: 2011-08-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2013-09-24
• Last updated: 2019-03-19

Locations

1 site across 1 country: Japan