Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer

NCT01592617 | Unknown Phase 2 DMC

• 2 other identifiers: S488410LPUMIN000007873
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

cancer vaccine; HLA-A*24:02; lung cancer; CTL

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• 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.

• 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.

Study Arms (1)

S-488410

EXPERIMENTAL

Drug: S-488410

Interventions

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).

Also known as: S-488410 (S-488401, S-488402, S-488403).

S-488410

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced NSCLC that cannot undergo curative surgery.
• Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
• Histologically diagnosed NSCLC.
• Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
• ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
• Life expectancy \> 3 months.
• Age between 20 to 79
• Male or Female.
• In patients or out patients.
• Able and willing to give valid written informed consent.

You may not qualify if:

• Other malignancy requiring treatment
• radiation, immunotherapy, hyperthermia, or surgery.
• Active and uncontrolled infectious disease
• Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
• Autoimmune disease.
• HIV-Ab or antigen positive
• Prior anti-cancer therapy within 4 weeks
• Laboratory values as follows: 2000\<mm3 \< WBC \< 15000/mm3, Platelet count \< 50000/mm3, Asparate transaminase \> 5 X cutoff value, Alanine transaminase \> 5 X cutoff value, Total bilirubin \> 3 X cutoff value, and Serum creatinine \> 3X cutoff value.
• Patients knows HLA-A type.
• Breastfeeding and Pregnancy (woman of child bearing potential)
• Refusal of pregnancy conception.
• Treated with S-488401, S-488402, or S-488403.
• Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
• Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.

Sponsors & Collaborators

• Shiga University: lead
• Showa University: collaborator
• Fukushima Medical University: collaborator
• Tohoku University: collaborator
• Shionogi: collaborator
• Tokyo University: collaborator
• University of Chicago: collaborator

Study Sites (1)

Department of Medical Oncology, Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

Related Publications (7)

• 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.

  PMID: 19459850 BACKGROUND

• 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.

  PMID: 18770861 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.

  PMID: 18452554 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.

  PMID: 18297458 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.

  PMID: 18089789 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.

  PMID: 17784873 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.

  PMID: 17079454 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yataro Daigo, MD, PhD

  Department of Medical Oncology, Shiga University of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology, Director of Cancer Center

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 7, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

JP (1)