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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000007873 | Registry Identifier | UMIN: University Hospital Medical Information Network |
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| Name | Class |
|---|---|
| Showa University | OTHER |
| Fukushima Medical University | OTHER |
| Tohoku University | OTHER |
| Shionogi |
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The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.
The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.
The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-488410 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-488410 | Drug | In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each). |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients. | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| CTL response between HLA-A24:02 and non-HLA-A24:02 | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. | |
| PFS and ORR between HLA-A24:02 and non-HLA-A24:02 | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yataro Daigo, MD, PhD | Department of Medical Oncology, Shiga University of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Shiga University of Medical Science Hospital | ÅŒtsu | Shiga | 520-2192 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19459850 | Background | Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14. | |
| 18770861 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| INDUSTRY |
| Tokyo University | OTHER |
| University of Chicago | OTHER |
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|
| PFS and OS between CTL response positive and negative | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. |
| Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. |
| Identification of biomarkers for efficacy and safety that are mentioned above | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. |
| Harao M, Hirata S, Irie A, Senju S, Nakatsura T, Komori H, Ikuta Y, Yokomine K, Imai K, Inoue M, Harada K, Mori T, Tsunoda T, Nakatsuru S, Daigo Y, Nomori H, Nakamura Y, Baba H, Nishimura Y. HLA-A2-restricted CTL epitopes of a novel lung cancer-associated cancer testis antigen, cell division cycle associated 1, can induce tumor-reactive CTL. Int J Cancer. 2008 Dec 1;123(11):2616-25. doi: 10.1002/ijc.23823. |
| 18452554 | Background | Mizukami Y, Kono K, Daigo Y, Takano A, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Detection of novel cancer-testis antigen-specific T-cell responses in TIL, regional lymph nodes, and PBL in patients with esophageal squamous cell carcinoma. Cancer Sci. 2008 Jul;99(7):1448-54. doi: 10.1111/j.1349-7006.2008.00844.x. Epub 2008 Apr 30. |
| 18297458 | Background | Daigo Y, Nakamura Y. From cancer genomics to thoracic oncology: discovery of new biomarkers and therapeutic targets for lung and esophageal carcinoma. Gen Thorac Cardiovasc Surg. 2008 Feb;56(2):43-53. doi: 10.1007/s11748-007-0211-x. Epub 2008 Feb 24. |
| 18089789 | Background | Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243. |
| 17784873 | Background | Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x. |
| 17079454 | Background | Hayama S, Daigo Y, Kato T, Ishikawa N, Yamabuki T, Miyamoto M, Ito T, Tsuchiya E, Kondo S, Nakamura Y. Activation of CDCA1-KNTC2, members of centromere protein complex, involved in pulmonary carcinogenesis. Cancer Res. 2006 Nov 1;66(21):10339-48. doi: 10.1158/0008-5472.CAN-06-2137. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |