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Clinical Trials/EUCTR2011-005014-12-DE
EUCTR2011-005014-12-DE
Active, not recruiting
Not Applicable

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Immune Response, and Clinical Efficacy of Cancer Peptide Vaccine S-488210 in Patients with Unresectable Locoregionally Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Shionogi & Co., Ltd.0 sites92 target enrollmentApril 10, 2012
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Shionogi & Co., Ltd.
Enrollment
92
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 10, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Confirmed to be HLA\-A\*02:01\-positive (Phase 1 part only)
  • •2\. Has unresectable locoregionally recurrent and/or metastatic HNSCC after failure of platinum based chemotherapy (including patients who are intolerant to platinum based chemotherapy due to adverse or toxic effects)For patients who can be treated with radiotherapy according to national guidelines, radiotherapy treatment, including hyperfractionation radiotherapy or radiotherapy with concurrent systemic therapy, must be completed before enrollment.
  • •3\. Has previously received platinum based chemotherapy containing either cisplatin or carboplatin as monotherapy or in combination with radiation
  • •4\. Has histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • •5\. Has the presence of measurable disease as defined by response evaluation criteria in solid tumors (RECIST) that is confirmed on imaging within 4 weeks before enrollment
  • •6\. Has an ECOG PS of 0 or 1 within 2 weeks before enrollment
  • •7\. Has an expected life span of at least 3 months from the time of enrollment
  • •8\. Is willing and able to provide a tumor tissue sample
  • •9\. Is a male or female patient aged \>/ \= 18 years at enrollment
  • •10\. Has been informed of the full nature and purpose of the study, including possible risks and side effects, and has been given ample time and opportunity to read and understand this information, and has signed the ICF

Exclusion Criteria

  • •1\. Has been treated with 3 or more chemotherapy regimens
  • •2\. Is human immunodeficiency virus positive, hepatitis B surface antigen
  • •positive, hepatitis C virus positive, or has other positive laboratory tests
  • •suggestive of active infection
  • •3\. Has human papilloma virus\-positive tumor (Phase 2 only)
  • •4\. Has any other malignant disease within the past 3 years, except for
  • •cervical carcinoma in situ or skin cancers other than melanoma
  • •5\. Has brain metastasis
  • •6\. Has received any of the following within 28 days of enrollment: anti malignant tumor drugs, immunosuppressants, corticosteroids, radiation therapy, immunotherapy, thermotherapy, and/or major surgery
  • •7\. Has an uncontrolled systemic or active infection

Outcomes

Primary Outcomes

Not specified

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