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    Summary
    EudraCT Number:2011-005014-12
    Sponsor's Protocol Code Number:1122P1811
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-005014-12
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 of Peptide Vaccine S-488210 in Patients with Head and Neck Squamous Cell Carcinoma
    A.4.1Sponsor's protocol code number1122P1811
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShionogi & Co., Ltd.
    B.1.3.4CountryJapan
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportShionogi & Co., Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi & Co., Ltd.
    B.5.2Functional name of contact pointKenji Igarashi
    B.5.3 Address:
    B.5.3.1Street Address12F, Hankyu Terminal Bldg., 1-4, Shibata 1-chome, Kita-ku
    B.5.3.2Town/ cityOsaka
    B.5.3.3Post code530-0012
    B.5.3.4CountryJapan
    B.5.4Telephone number+81664855082
    B.5.5Fax number+81663755780
    B.5.6E-mailkenji.igarashi@shionogi.co.jp
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code S-488210
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeS-488210
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Head and Neck Squamous Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    * Phase 1 part
    To evaluate the safety and tolerability of S-488210 in HLA A*02:01-positive patients with head and neck squamous cell carcinoma (HNSCC) receiving 4 vaccinations of S-488210

    * Phase 2 part
    To compare the overall survival between HLA-A*02:01-positive and HLA-A*02:01-negative patients receiving S-488210
    E.2.2Secondary objectives of the trial
    * Phase 1 part
    To evaluate the specific CTL response

    * Phase 2 part
    To evaluate:
    - The specific CTL response
    - The antitumor efficacy
    - The safety and tolerability
    - Any improvement in general health status based on EORTC QLQ-C30 and QLQ-H&N35 questionnaires
    - The progression-free survival
    - The overall survival
    E.2.3Trial contains a sub-study No
    E.3Principal 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)
    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 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
    E.4Principal 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 part 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
    8. Has uncontrolled comorbidities such as hepatic insufficiency, renal insufficiency, heart failure, chronic obstructive pulmonary disease, bleeding disorders, or metabolic disease
    9. Has an autoimmune disease including rheumatoid arthritis, systemic lupus erythematosus, or psoriasis
    10. Has a current drug allergy or a past history of drug allergy
    11. Has a past history of hypersensitivity to vaccines (eg, prophylactic vaccination)
    12. Has received any systematic radiation therapy within 28 days of enrollment
    13. Has inadequate bone marrow function, hepatic, or renal function test values that meet the following criteria within 2 weeks before enrollment:
    - White blood cell count <2000/mm^3 or >20 000/mm^3
    - Platelet count <50 000/mm^3
    - Aspartate aminotransferase or alanine aminotransferase >5 × the upper limit of the reference range
    - Total bilirubin >3 × the upper limit of the reference range
    - Serum creatinine >3 × the upper limit of the reference range
    14. Is a female who is breastfeeding or pregnant, or who might be pregnant
    15. Cannot or does not intend to use adequate means of contraception (barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel]; hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings]; or intrauterine devices) from enrollment until 12 weeks after final study drug administration
    16. Has received another investigational product (including clinical study drugs) within 60 days of enrollment
    17. Has received another investigational product (including clinical study drugs) within 28 days of enrollment, or still has adverse effects attributable to a previous investigational product at the time of
    screening
    18. Has previously been genotyped for HLA status (Phase 2 part only)
    E.5 End points
    E.5.1Primary end point(s)
    * Phase 1 part
    AE grades assessed by CTCAE Version 4.0; incidence and causality of AEs

    * Phase 2 part
    Comparison of overall survival between HLA-A*02:01-positive and HLA-A*02:01-negative patients
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival (OS) will be assessed for the Phase 1 part 6 months after the last patient has completed Step 1 of the Phase 1 part, when all patients complete Step 1 of the Phase 2 part, then 6, 12, and 18 months following completion of Step 1 of the Phase 2 part.
    Overall survival will be assessed for the Phase 2 part when all patients complete Step 1 of the Phase 2 part, then 6, 12, and 18 months following completion of Step 1 of the Phase 2 part.
    Patients who discontinue the study (either before or after Step 1) will also be followed up at these time points.
    E.5.2Secondary end point(s)
    * Phase 1 part
    Immune response, as evidenced by CTL induction rate

    * Phase 2 part
    - Immune response, as evidenced by CTL induction rate
    - Progression free survival
    - Overall survival
    - Antitumor efficacy, as evidenced by: objective response rate (complete response [CR] + partial response [PR] to the analysis population), overall response rate (CR + PR + stable disease [SD] to the analysis population) according to RECIST Version 1.1
    - AE grades assessed by CTCAE Version 4.0; incidence and causality of AEs
    - Improvement in the general health status of patients compared with baseline based on the EORTC QLQ-C30 and QLQ-H&N35 questionnaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS and PFS Phase 1 6 months after the last patient has completed Step 1 of the Phase 1 part, when all patients complete Step 1 of the Phase 2, then 6, 12 and 18 months following completion of Step 1 of Phase 2.
    OS and PFS Phase 2 when all patients complete Step 1 of the Phase 2 part, then 6, 12 and 18 months following completion of Step 1 of the Phase 2 part
    Patients who discontinue the study (either before or after Step 1) will also be followed up at these time points.
    Blood samples for specific CTL measurement for Phases 1 and 2 at visit 1, 5, 9 and 13.
    Tumor evaluation will be assessed every 8 weeks for Phases 1 and 2.
    Any improvement in general health status of patients compared with baseline will be assessed every 8 weeks from previous until Visit 25 for Phases 1 and 2.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Date when evaluation of overall survival is completed.
    See section 5.6 Study Termination, of the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 92
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated as per standard of care after the end of the trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
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