NCT01950156

Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer

Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) 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 three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*2402-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\*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers. The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402-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*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant	Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A\*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant.

Timeline

• Start date: 2011-09-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2013-09-25
• Last updated: 2019-03-19

Locations

1 site across 1 country: Japan