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    Summary
    EudraCT Number:2011-000853-22
    Sponsor's Protocol Code Number:CA184-162
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000853-22
    A.3Full title of the trial
    A randomized, open-label, two-arm phase II trial comparing the efficacy of sequential ipilimumab versus best supportive care following first-line chemotherapy in subjects with unresectable locally advanced/metastatic gastric or gastro-esophageal junction cancer.
    Studio clinico di fase II, randomizzato, in aperto, a doppio braccio, che confronta l'™efficacia di ipilimumab verso la Miglior Terapia di Supporto somministrato dopo chemioterapia di prima linea in soggetti con tumore gastrico o della giunzione gastro-esofagea, non resecabile, localmente avanzato o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An efficacy study in gastric and gastroesophageal junction cancer comparing ipilimumab versus standard of care immediately following first line chemotherapy
    Studio di efficacia in pazienti con tumore gastrico o della giunzione gastro-esofagea che confronta il trattamento con ipilimumab verso lo standard terapeutico somministrati immediatamente a seguire la chemioterapia di prima linea
    A.4.1Sponsor's protocol code numberCA184-162
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryItaly
    B.5.6E-mailclinical.trials@bms.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.3.1Product nameipilimumab
    D.3.2Product code NA
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016 / MDX010
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Locally advanced (unresectable) or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
    adenocarcinoma localmente avanzato (non resecabile) o metastatico della giunzione gastrica o gastro-esofagea
    E.1.1.1Medical condition in easily understood language
    Gastric cancer
    cancro gastrico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10030137
    E.1.2Term Oesophageal adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the study is to compare the efficacy of ipilimumab and standard of care immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
    L'obiettivo dello studio è quello di confrontare l'efficacia di ipilimumab e dello standard terapeutico immediatemente a seguire la chemioterapia di prima linea nel trattamento del cancro gastrico o della giunzione gastro-esogafea non resecabile o metastatico
    E.2.2Secondary objectives of the trial
    • progression free survival (PFS) per modified WHO criteria, • Overall survival (OS), • immune-related best overall response rate (irBORR)
    - sopravvivenza libera da progressione (PFS) in accordo ai criteri WHO modificati; - sopravvivenza globale (OS); - tasso di risposta globale migliore immuno correlata (irBORR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction • Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression • ECOG performance status of 0 or 1 • Measurable disease by modified WHO criteria (unless complete response for previous chemotherapy)
    - Adenocarcinoma della giunzione gastrica o gastro-esofagea, non resecabile, localmente avanzato o metastatico, confermato istologicamente
    - Già ricevuta chemioterapia di prima linea con combinazione di fluoropirimidina e platino senza progressione della malattia
    - Performance status ECOG pari a 0 oppure 1
    - Malattia misurabile secondo i criteri WHO modificati (a meno che non si verifichi risposta completa per il precedente trattamento chemioterapico)
    E.4Principal exclusion criteria
    •Known HER2 positive status •Radiological evidence of brain metastases •History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment •Inadequate hematologic, renal and hepatic function
    - stato conosciuto HER2 positivo; evidenza radiologica di metastasi cerebrali; - storia di malattia autoimmune o immune severa che ha richiesto un prolungato trattamento immunosoppressivo; - funzionalità ematologica, renale ed epatica inadeguate
    E.5 End points
    E.5.1Primary end point(s)
    Immune-related progression free survival (irPFS) as per assessment of a blinded Independent Review Committee (IRC) according to immune related response criteria (irRC) guidelines.
    sopravvivenza libera da progressione immuno correlata (irPFS) valutata da una commisione di revisione indipendente (IRC) in accordo alle linee guida dei criteri di risposta immuno correlati (irRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    91 irPFS events
    91 eventi di sopravvivenza libera da progressione immuno correlata (irPFS)
    E.5.2Secondary end point(s)
    • progression free survival (PFS) per modified WHO criteria, • Overall survival (OS), • immune-related best overall response rate (irBORR)
    - sopravvivenza libera da progressione (PFS) in accordo ai criteri WHO modificati; - sopravvivenza globale (OS); - tasso di risposta globale migliore immuno correlata (irBORR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    91 irPFS events
    91 eventi di sopravvivenza libera da progressione immuno correlata (irPFS)
    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 Yes
    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
    Biomarker Assessments (Absolute Lymphocyte Count); Outcomes Research Assessments
    Biomarker Assessments (Absolute Lymphocyte Count); Outcomes Research Assessments
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA16
    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
    Hong Kong
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Russian Federation
    Singapore
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the last subject
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months33
    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.1.1Number of subjects for this age range: 0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 152
    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)
    At study end,subjects who continue to demonstrate clinical benefit will be eligible to receive ipilimumab via study extension,rollover study,or another mechanism at sponsor’s discretion.Sponsor may terminate access to study drug if any of the following occur:marketing application rejected by health authority;study terminated due to safety concerns;subject canObtain medication from a government sponsored/private healthProgram;or therapeuticAlternatives become available in local market
    A fine studio i soggetti che continuano a dimostrare beneficio clinico potranno ricevere ipilimumab tramite estensione dello studio, studio rollover o altro mezzo a scelta dello Sponsor. Lo Sponsor può terminare l’accesso al farmaco in studio in caso di: richiesta di AIC respinta dall’autorità regolatoria;studio terminato per questioni di sicurezza; i soggetti possono ricevere il trattamento tramite programma sanitario statale/privato; diventano disponibili alternative terapeutiche.
    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 Decision2012-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-02
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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