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| ID | Type | Description | Link |
|---|---|---|---|
| 22-15 | Other Identifier | Shiga University |
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| Name | Class |
|---|---|
| Tokyo University | OTHER |
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In this study, the investigators examine using a combination of two types of HLA-A*2402 (or HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 or HLA-A*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.
In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402 or HLA-A*0201-positive advanced solid tumor patients who are refractory to standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLA-A*2402 restricted peptides | Experimental | HLA-A*2402 restricted peptides with adjuvant |
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| HLA-A*0201 restricted peptides | Experimental | HLA-A*0201 restricted peptides with adjuvant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLA-A*2402 or A*0201 restricted peptides | Biological | Open Label, Non-Randomized, Safety/Efficacy study:
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety: the number of adverse events of vaccination therapy. | 2 months | |
| Evaluation of clinical efficacy: Overall survival. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels. | 2 months | |
| Evaluation of clinical efficacy: Progression free survival. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yataro Daigo, MD, PhD | Shiga University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiga University of Medical Science Hospital | Ohtsu | Shiga | 520-2192 | Japan |
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| ID | Term |
|---|---|
| C438506 | HLA-A*24:02 antigen |
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| Evaluation of clinical efficacy: Tumor markers. | 2 months |
| Evaluation of clinical efficacy: Objective response rate. | 2 months |