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    Summary
    EudraCT Number:2013-005274-22
    Sponsor's Protocol Code Number:1408P1921
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-005274-22
    A.3Full title of the trial
    A multicenter, open-label, phase 2 study of S-588410 as
    maintenance monotherapy after first-line platinum-containing
    chemotherapy in patients with advanced
    and/or metastatic bladder cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, open-label, phase 2 study of S-588410 as
    a single maintenance therapy after a first treatment with platinum-containing chemotherapy agents in patients with advanced cancer of the bladder and/or bladder cancer that has spread to other areas of the body.
    A.4.1Sponsor's protocol code number1408P1921
    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 pointCorporate Communications Department
    B.5.3 Address:
    B.5.3.1Street Address1-8, Doshomachi 3-chome
    B.5.3.2Town/ cityChuo-ku, Osaka
    B.5.3.3Post code541-0045
    B.5.3.4CountryJapan
    B.5.4Telephone number+8166209 7885
    B.5.6E-mailshionogiclintrial588410@shionogi.com
    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-588410
    D.3.4Pharmaceutical form Emulsion 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-588410
    D.3.9.3Other descriptive nameS-588410
    D.3.9.4EV Substance CodeSUB166242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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) Yes
    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
    Advanced and/or metastatic bladder cancer, which is under control according to first-line chemotherapy.
    E.1.1.1Medical condition in easily understood language
    advanced cancer of the bladder and/or bladder cancer that has spread to other areas of the body, but which is under control as a result of the first treatment given.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    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
    To evaluate the specific cytotoxic T lymphocyte (CTL) response in human leukocyte antigen (HLA)-A*24:02 positive patients receiving S-588410 for 12 weeks.
    E.2.2Secondary objectives of the trial
    ● To evaluate the specific CTL induction over time in HLA-A*24:02-positive patients receiving S-588410 for 1 year.
    ● To estimate antitumor effect in HLA-A*24:02-positive patients receiving S-588410.
    ● To estimate progression-free survival (PFS) in HLA-A*24:02-positive patients receiving S-588410.
    ● To estimate overall survival (OS) in HLA-A*24:02-positive patients receiving S-588410.
    ● To evaluate the safety and tolerability in patients receiving S-588410.
    ● To assess the general health status in terms of European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and Euro-QOL 5 dimension 5 level version (EQ-5D-5L) questionnaires in HLA-A*24:02-positive patients receiving S- 588410.
    ● To collect data of tumor evaluation, PFS, OS, and EORTC QLQ-C30 and EQ-5D-5L questionnaires in HLA-A*24:02-negative patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Patients with advanced and/or metastatic bladder cancer (including urothelial cancer of renal pelvis, ureters, and urethra) who have complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the end of at least 4 cycles of firstline platinum-containing systemic chemotherapy.Common Terminology Criteria for Adverse Events [CTCAE] version 4.03.)
    ● Patients who are male or female aged ≥20 years at the time of informed consent.
    ● Patients with the ECOG PS 0 or 1 at enrollment.
    E.4Principal exclusion criteria
    ● Patients who have progressive disease (PD) on RECIST version 1.1 at the end of at least 4 cycles of first-line platinum-containing chemotherapy.
    ● Patients who are judged to have clinically progressive symptoms at the end of at least 4 cycles of first-line platinum-containing chemotherapy by the investigator or subinvestigator.
    ● Patients with a history of malignant cancer (except for carcinoma in situ or intra-mucosal cancer that resolved with endoscopic therapy) within 5 years before enrollment.
    ● Patients who received any prior therapies for target disease within 3 weeks before the first administration of S-588410.
    ● Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment.
    – Anti-malignant tumor drug
    – Systemic corticosteroid (except for corticosteroid defined as the equivalent of prednisone ≤ 10 mg/day orally)
    – Systemic immunosuppressant drug
    – Immunotherapy
    – Radiotherapy (except for restricted radiotherapy for pain relief of bone metastasis) for the target disease
    – Surgical therapy for the target disease
    – Hyperthermia for the target disease
    – Herbal medicine with anti-tumor or immunosuppressant effect
    – Other investigational new products
    ● Patients who have severe (CTCAE version 4.03 grade 3 or higher) concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease, with the exception of any symptoms and/or signs associated with target disease.
    ● Patients who have the following laboratory data with grade 3 or higher according to CTCAE version 4.03 criteria within 28 days before enrollment.
    – White blood cell count <2000/mm3 or >100 000/mm3
    – Platelet count <50 000/mm3
    – Hemoglobin <8.0 g/dL
    – Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5.0 × the upper limit of normal (ULN)
    – Total bilirubin >3.0 × ULN
    – Serum creatinine >3.0 × ULN
    ● Patients who have known human immunodeficiency virus infection.
    ● Patients with uncontrolled systemic or active infection.
    ● Patients who had any diseases with the risk of sudden death within 12 months before enrollment.
    [Examples]
    – Myocardial infarction
    – Unstable angina
    – Coronary or peripheral artery bypass graft surgery
    – Thrombotic or embolic events such as pulmonary embolism, deep vein thrombosis, or transient ischemic attack
    ● Patients who have known brain metastases.
    ● Patients with a history or evidence of autoimmune diseases and/or immunodeficiency disorders.
    ● Patients with a history of severe (CTCAE version 4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation.
    ● Female patients who are lactating or pregnant. Female patients who are of childbearing potential, not included in any of the following, are positive for the pregnancy test at enrollment.
    – Postmenopausal woman (at least 2 years since their last regular menstrual period without any other medical reason)
    – Women who are surgically sterile by hysterectomy and/or bilateral oophorectomy, or by tubal ligation
    ● Patients who cannot or do not intend to practice effective contraception (barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel]; hormonal contraceptives [implants, injectables, combination oral contraceptives, or transdermal patches]; or intrauterine devices) as per physicians' recommendations from enrollment to 90 days after completion or discontinuation of study treatment.
    ● Patients who received any other investigational products within 28 days or 5 half-lives of the investigational products before enrollment whichever is longer.
    E.5 End points
    E.5.1Primary end point(s)
    [S-588410 Group]: CTL induction rate within 12 weeks after initial dose, defined as the proportion of patients who show CTL induction to at least any one of the 5 antigens.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    [S-588410 Group]:
    ● CTL induction rate within 1 year after initial dose, defined as the proportion of patients who show CTL induction to at least any one of the 5 antigens.

    [S-588410 Group and Observation Group]:
    ● Response rate (RR), defined as the proportion of patients who are assessed as CR or PR by using RECIST version 1.1 and immune-related response criteria (irRC), respectively.
    ● Disease control rate (DCR), defined as the proportion of patients who are assessed as CR, PR, or SD by using RECIST version 1.1 and irRC, respectively.
    ● Any response rate in image analysis such as tumor cavitation, defined as the proportion of patients who show any tumor change in image analysis (eg, tumor
    cavitation).
    ● PFS, defined as the time interval from the date of enrollment to the date of progression (progressive disease based on RECIST version 1.1, clinically progressive
    symptoms, or withdrawal due to aggravation of the target disease) or death due to any cause, whichever occurs first.
    ● OS, defined as the time interval from the date of enrollment to the date of death due to any cause.
    ● Change in QOL, defined as change from baseline in the global health status, the function scales, and the symptom scales on the EORTC QLQ C30 questionnaire, and the index value and the EQ visual analog scale (VAS) on the EQ-5D questionnaire, respectively. Baseline is defined as the value obtained at Visit 1 (pre-dose).
    E.5.2.1Timepoint(s) of evaluation of this end point
    108 weeks
    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) No
    E.7.1.1First administration to humans No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Observation group
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    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. Overall survival assessment will be conducted after 3 years from the enrolment of the last patient.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 84
    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)
    Follow-up assessments will be performed in all enrolled patients for 3 years after enrollment of last patient. The following items (survival or death, progression or no progression, and therapy for the target disease) will be reported to the sponsor.
    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 Decision2014-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-02
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