{ "FullStudy":{ "Rank":218163, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511913", "OrgStudyIdInfo":{ "OrgStudyId":"CA184-143" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"ENCEPP/SDPP/2723", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Euro. Ntwk. of Ctrs. for Pharmacoepidemiology and Pharmacovigilance" } ] }, "Organization":{ "OrgFullName":"Bristol-Myers Squibb", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma", "OfficialTitle":"A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma", "Acronym":"IMAGE" }, "StatusModule":{ "StatusVerifiedDate":"December 2018", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 30, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 11, 2020", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"November 28, 2020", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"November 15, 2011", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 28, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 31, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Bristol-Myers Squibb", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting.", "DetailedDescription":"Time Perspective: this study does have a retrospective component involving a subset of patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Advanced Cutaneous Melanoma" ] }, "KeywordList":{ "Keyword":[ "Unresectable or metastatic cutaneous melanoma" ] } }, "DesignModule":{ "StudyType":"Observational", "PatientRegistry":"No", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"1800", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Ipilimumab treated cohort of 1000 patients", "ArmGroupDescription":"All patients identified and followed prospectively", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Non-Interventional" ] } },{ "ArmGroupLabel":"Non-Ipilimumab treated cohort of 800 patients", "ArmGroupDescription":"600 patients will be identified and followed prospectively, and 200 patients retrospectively identified and followed", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Non-Interventional" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Non-Interventional", "InterventionDescription":"Non-Interventional", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ipilimumab treated cohort of 1000 patients", "Non-Ipilimumab treated cohort of 800 patients" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting", "PrimaryOutcomeTimeFrame":"Every 12 months up to 5 years" },{ "PrimaryOutcomeMeasure":"Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events", "PrimaryOutcomeTimeFrame":"Every 12 months up to 5 years" },{ "PrimaryOutcomeMeasure":"Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab", "PrimaryOutcomeTimeFrame":"Every 12 months up to 5 years" },{ "PrimaryOutcomeMeasure":"Patterns of disease monitoring as observed in a real-world setting", "PrimaryOutcomeDescription":"To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination", "PrimaryOutcomeTimeFrame":"Every 12 months up to 5 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma", "SecondaryOutcomeTimeFrame":"Every 12 months up to 5 years" },{ "SecondaryOutcomeMeasure":"Resource utilization associated with advanced melanoma treatment", "SecondaryOutcomeDescription":"Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs", "SecondaryOutcomeTimeFrame":"Every 12 months up to 5 years" },{ "SecondaryOutcomeMeasure":"Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma", "SecondaryOutcomeTimeFrame":"Every 12 months up to 5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\nDiagnosis of unresectable or metastatic melanoma\nAge of 18 years or older at time of entry into the study\nPatients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent\nIpilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment\n\nExclusion Criteria:\n\nCurrent or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma)\nCurrent use of therapy to treat a primary cancer other than melanoma", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Eligible patients will be selected from approximately 200 medical practice sites (e.g. community-based, office-based, hospital-based, academic setting) in several European Union countries, Central America, North America, and South America, as well as Australia and Israel.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bristol-Myers Squibb", "OverallOfficialAffiliation":"Bristol-Myers Squibb", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Local Institution", "LocationCity":"Gilbert", "LocationState":"Arizona", "LocationZip":"85234", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Hot Springs", "LocationState":"Arkansas", "LocationZip":"71913", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Encinitas", "LocationState":"California", "LocationZip":"92024", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"La Jolla", "LocationState":"California", "LocationZip":"92093", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Long Beach", "LocationState":"California", "LocationZip":"90813", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Los Angeles", "LocationState":"California", "LocationZip":"90025", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Denver", "LocationState":"Colorado", "LocationZip":"80218", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Washington", "LocationState":"District of Columbia", "LocationZip":"20010", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Lakeland", "LocationState":"Florida", "LocationZip":"33085", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Miami Beach", "LocationState":"Florida", "LocationZip":"33140", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Orange Park", "LocationState":"Florida", "LocationZip":"32073", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Chicago", "LocationState":"Illinois", "LocationZip":"60612", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Niles", "LocationState":"Illinois", "LocationZip":"60714", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Detroit", "LocationState":"Michigan", "LocationZip":"48201", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Hattiesburg", "LocationState":"Mississippi", "LocationZip":"39401", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Lincoln", "LocationState":"Nebraska", "LocationZip":"18015", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Morristown", "LocationState":"New Jersey", "LocationZip":"07960", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Canton", "LocationState":"Ohio", "LocationZip":"44178", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Columbus", "LocationState":"Ohio", "LocationZip":"43219", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Middletown", "LocationState":"Ohio", "LocationZip":"45042", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Portland", "LocationState":"Oregon", "LocationZip":"97213", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Knoxville", "LocationState":"Tennessee", "LocationZip":"37920", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Everett", "LocationState":"Washington", "LocationZip":"98201", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Caba", "LocationZip":"C1417DNT", "LocationCountry":"Argentina" },{ "LocationFacility":"Local Institution", "LocationCity":"Caba", "LocationZip":"C1426ANZ", "LocationCountry":"Argentina" },{ "LocationFacility":"Local Institution", "LocationCity":"Cordoba", "LocationZip":"X5006HBF", "LocationCountry":"Argentina" },{ "LocationFacility":"Local Institution", "LocationCity":"Rosario- Santa Fe", "LocationZip":"S2000KZE", "LocationCountry":"Argentina" },{ "LocationFacility":"Local Institution", "LocationCity":"Tucuman", "LocationZip":"T4000GTB", "LocationCountry":"Argentina" },{ "LocationFacility":"Local Institution", "LocationCity":"Canberra", "LocationState":"Australian Capital Territory", "LocationZip":"02605", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Corrimal", "LocationState":"New South Wales", "LocationZip":"02518", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Lismore", "LocationState":"New South Wales", "LocationZip":"02480", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Port Macquarie", "LocationState":"New South Wales", "LocationZip":"02444", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Tamworth", "LocationState":"New South Wales", "LocationZip":"02340", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Tweeds Head", "LocationState":"New South Wales", "LocationZip":"02485", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Wagga Wagga", "LocationState":"New South Wales", "LocationZip":"2650", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Waratah", "LocationState":"New South Wales", "LocationZip":"02298", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Cairns", "LocationState":"Queensland", "LocationZip":"4870", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Douglas", "LocationState":"Queensland", "LocationZip":"04810", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Greenslopes", "LocationState":"Queensland", "LocationZip":"4120", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Adelaide", "LocationState":"South Australia", "LocationZip":"05000", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Bedford Park", "LocationState":"South Australia", "LocationZip":"05042", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Frankston", "LocationState":"Victoria", "LocationZip":"03199", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Malvern", "LocationState":"Victoria", "LocationZip":"03144", "LocationCountry":"Australia" },{ "LocationFacility":"Local Institution", "LocationCity":"Graz", "LocationZip":"A-8036", "LocationCountry":"Austria" },{ "LocationFacility":"Local Institution", "LocationCity":"Linz", "LocationZip":"A-4020", "LocationCountry":"Austria" },{ "LocationFacility":"Local Institution", "LocationCity":"Salzburg", "LocationZip":"A-5020", "LocationCountry":"Austria" },{ "LocationFacility":"Local Institution", "LocationCity":"St Poelten", "LocationZip":"A-3100", "LocationCountry":"Austria" },{ "LocationFacility":"Local Institution", "LocationCity":"Vienna", "LocationZip":"A-1090", "LocationCountry":"Austria" },{ "LocationFacility":"Local Institution", "LocationCity":"Brasschaat", "LocationZip":"2930", "LocationCountry":"Belgium" },{ "LocationFacility":"Local Institution", "LocationCity":"Brussels", "LocationZip":"1200", "LocationCountry":"Belgium" },{ "LocationFacility":"Local Institution", "LocationCity":"Edegem", "LocationZip":"2650", "LocationCountry":"Belgium" },{ "LocationFacility":"Local Institution", "LocationCity":"Haint Saint Paul", "LocationZip":"7100", "LocationCountry":"Belgium" },{ "LocationFacility":"Local Institution", "LocationCity":"Hasselt", "LocationZip":"3500", "LocationCountry":"Belgium" },{ "LocationFacility":"Local Institution", "LocationCity":"Kortrijk", "LocationZip":"8500", "LocationCountry":"Belgium" },{ "LocationFacility":"Local Institution", "LocationCity":"Leuven", "LocationZip":"3000", "LocationCountry":"Belgium" },{ "LocationFacility":"Local Institution", "LocationCity":"Moncton", "LocationState":"New Brunswick", "LocationZip":"E1C 6Z8", "LocationCountry":"Canada" },{ "LocationFacility":"Local Institution", "LocationCity":"London", "LocationState":"Ontario", "LocationZip":"N6C 6B5", "LocationCountry":"Canada" },{ "LocationFacility":"Local Institution", "LocationCity":"Mississauga", "LocationState":"Ontario", "LocationZip":"L5M 2N1", "LocationCountry":"Canada" },{ "LocationFacility":"Local Institution", "LocationCity":"Windsor", "LocationState":"Ontario", "LocationZip":"N8W 2X3", "LocationCountry":"Canada" },{ "LocationFacility":"Local Institution", "LocationCity":"Saskatoon", "LocationState":"Saskatchewan", "LocationZip":"S7N 4H4", "LocationCountry":"Canada" },{ "LocationFacility":"Local Institution", "LocationCity":"Québec", "LocationZip":"G1R 2J6", "LocationCountry":"Canada" },{ "LocationFacility":"Local Institution", "LocationCity":"Bayonne", "LocationZip":"64100", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Besancon", "LocationZip":"25000", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Boulogne sur Mer", "LocationZip":"62200", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Boulogne", "LocationZip":"92104", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Brest Cedex", "LocationZip":"29609", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Clermont Ferrand Cédex 1", "LocationZip":"63003", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Dijon", "LocationZip":"21079", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Grenoble Cédex", "LocationZip":"38043", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Lille Cedex", "LocationZip":"59037", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Limoges Cedex", "LocationZip":"87042", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Montauban", "LocationZip":"82000", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Mougins", "LocationZip":"06250", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Nouvelle Caledonie", "LocationZip":"98849", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Paris Cedex 10", "LocationZip":"75475", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Pierre Bénite", "LocationZip":"69495", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Quimper", "LocationZip":"29107", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Soissons cedex", "LocationZip":"02209", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Strasbourg Cedex", "LocationZip":"67065", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Vandoeuvre Les Nancy", "LocationZip":"54500", "LocationCountry":"France" },{ "LocationFacility":"Local Institution", "LocationCity":"Augsburg", "LocationZip":"86156", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Bochum", "LocationZip":"44791", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Buxtehude", "LocationZip":"21614", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Chemnitz", "LocationZip":"09117", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Darmstadt", "LocationZip":"64297", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Dessau-Roblau", "LocationZip":"06847", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Dortmund", "LocationZip":"44137", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Dresden", "LocationZip":"01307", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Düsseldorf", "LocationZip":"40225", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Frankfurt", "LocationZip":"60590", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Gera", "LocationZip":"07548", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Halle/Saale", "LocationZip":"06120", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Hamburg", "LocationZip":"20099", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Hamburg", "LocationZip":"20246", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Hamburg", "LocationZip":"20253", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Hannover", "LocationZip":"30625", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Jena", "LocationZip":"07743", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Koblenz", "LocationZip":"56068", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Lüdenscheid", "LocationZip":"58515", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Magdeburg", "LocationZip":"39120", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Mainz", "LocationZip":"55131", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Mannheim", "LocationZip":"68167", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Marburg", "LocationZip":"35043", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Münster", "LocationZip":"48149", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Plauen", "LocationZip":"08529", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Quedlinburg", "LocationZip":"06484", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Recklinghausen", "LocationZip":"45657", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Rostock", "LocationZip":"18055", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Schwäbisch Hall", "LocationZip":"74523", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Stuttgart", "LocationZip":"70374", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Tübingen", "LocationZip":"72076", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Würzburg", "LocationZip":"97080", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Cholargos", "LocationState":"Athens", "LocationZip":"15562", "LocationCountry":"Greece" },{ "LocationFacility":"Local institution", "LocationCity":"Goudi", "LocationState":"Athens", "LocationZip":"11527", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institution", "LocationCity":"Neo Faliro", "LocationState":"Athens", "LocationZip":"18547", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institution", "LocationCity":"Heraklion", "LocationState":"Crete", "LocationZip":"71100", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institution", "LocationCity":"Neas Efkarpia", "LocationState":"Thessaloniki", "LocationZip":"56429", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institutio", "LocationCity":"Alexandroupolis", "LocationZip":"68100", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institution", "LocationCity":"Athens", "LocationZip":"11528", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institution", "LocationCity":"Athens", "LocationZip":"15233", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institution", "LocationCity":"Mezourlo", "LocationZip":"41334", "LocationCountry":"Greece" },{ "LocationFacility":"Local Institution", "LocationCity":"Cork", "LocationCountry":"Ireland" },{ "LocationFacility":"Local Institution", "LocationCity":"Dublin", "LocationCountry":"Ireland" },{ "LocationFacility":"Local Institution", "LocationCity":"Galway", "LocationCountry":"Ireland" },{ "LocationFacility":"Local Institution", "LocationCity":"Tullamore", "LocationCountry":"Ireland" },{ "LocationFacility":"Local Institution", "LocationCity":"Haifa", "LocationZip":"31096", "LocationCountry":"Israel" },{ "LocationFacility":"Local Institution", "LocationCity":"Tel Aviv", "LocationZip":"64239", "LocationCountry":"Israel" },{ "LocationFacility":"Local Institution", "LocationCity":"Tel Hashomer", "LocationZip":"52621", "LocationCountry":"Israel" },{ "LocationFacility":"Local Institution", "LocationCity":"Bydgoszcz", "LocationZip":"85-796", "LocationCountry":"Poland" },{ "LocationFacility":"Local Institution", "LocationCity":"Warszawa", "LocationZip":"02-781", "LocationCountry":"Poland" },{ "LocationFacility":"Local Institution", "LocationCity":"Wrocław", "LocationZip":"51-124", "LocationCountry":"Poland" },{ "LocationFacility":"Local Institution", "LocationCity":"Łódź", "LocationZip":"93-510", "LocationCountry":"Poland" },{ "LocationFacility":"Local Institution", "LocationCity":"Barcelona", "LocationZip":"08036", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Donostia", "LocationZip":"20014", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Las Palmas de Gran Canaria", "LocationZip":"35016", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Madrid", "LocationZip":"28007", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Madrid", "LocationZip":"28033", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Madrid", "LocationZip":"28034", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Madrid", "LocationZip":"28041", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Palma", "LocationZip":"07198", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Pamplona", "LocationZip":"31008", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Santa Cruz de Tenerife", "LocationZip":"38010", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Santander", "LocationZip":"39008", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Santiago De Compostela; A Coruña", "LocationZip":"15706", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Sevilla", "LocationZip":"41013", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Sta Cruz de Tenerife", "LocationZip":"35320", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Terrassa", "LocationZip":"08027", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Valladolid", "LocationZip":"47012", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Zaragoza", "LocationZip":"50009", "LocationCountry":"Spain" },{ "LocationFacility":"Local Institution", "LocationCity":"Baden", "LocationZip":"CH-5404", "LocationCountry":"Switzerland" },{ "LocationFacility":"Local Institution", "LocationCity":"Lugano", "LocationZip":"CH-6900", "LocationCountry":"Switzerland" },{ "LocationFacility":"Local Institution", "LocationCity":"Zürich", "LocationZip":"CH-8091", "LocationCountry":"Switzerland" },{ "LocationFacility":"Local Institution", "LocationCity":"Rhyl", "LocationState":"Denbigshire", "LocationZip":"LL18 5UJ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"London", "LocationState":"England", "LocationZip":"NW3 2QG", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Chelmsford, Essex", "LocationState":"Essex", "LocationZip":"CM1 7ET", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Southend", "LocationState":"Essex", "LocationZip":"SS0 0RY", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Belfast", "LocationState":"Ireland", "LocationZip":"BT9 7AB", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Cardiff", "LocationState":"South Glamorgan", "LocationZip":"CF14 2TL", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Birmingham", "LocationZip":"B15 2TH", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Bristol", "LocationZip":"BS2 8ED", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Exeter", "LocationZip":"EX2 5DW", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Hull", "LocationZip":"HU16 5JQ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Leeds", "LocationZip":"LS9 7TF", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Lincoln", "LocationZip":"LN2 5QY", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"London", "LocationZip":"SE1 9RT", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"London", "LocationZip":"SW3 6JJ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Oxfordshire", "LocationZip":"OX3 7LE", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Plymouth", "LocationZip":"PL6 8DH", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Poole", "LocationZip":"BH15 2JB", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Preston", "LocationZip":"PR2 9HT", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Staffordshire", "LocationZip":"ST46QG", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Taunton, Somerset", "LocationZip":"TA1 5DA", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Truro, Cornwall", "LocationZip":"TR1 3LJ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Wirral", "LocationZip":"CH63 4JY", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Wolverhampton", "LocationZip":"WS13 6NH", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Yeovil, Somerset", "LocationZip":"BA21 4AT", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"BMS Clinical Trials Disclosure", "SeeAlsoLinkURL":"http://www.bms.com/clinical_trials/Pages/home.aspx" },{ "SeeAlsoLinkLabel":"Investigator Inquiry form", "SeeAlsoLinkURL":"http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx" },{ "SeeAlsoLinkLabel":"FDA Safety Alerts and Recalls", "SeeAlsoLinkURL":"http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm" },{ "SeeAlsoLinkLabel":"BMS clinical trial educational resource", "SeeAlsoLinkURL":"https://www.bmsstudyconnect.com/s/US/English/USenHome" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "Brazil", "Mexico" ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008545", "ConditionMeshTerm":"Melanoma" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000018358", "ConditionAncestorTerm":"Neuroendocrine Tumors" },{ "ConditionAncestorId":"D000017599", "ConditionAncestorTerm":"Neuroectodermal Tumors" },{ "ConditionAncestorId":"D000009373", "ConditionAncestorTerm":"Neoplasms, Germ Cell and Embryonal" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000009380", "ConditionAncestorTerm":"Neoplasms, Nerve Tissue" },{ "ConditionAncestorId":"D000018326", "ConditionAncestorTerm":"Nevi and Melanomas" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10111", "ConditionBrowseLeafName":"Melanoma", "ConditionBrowseLeafAsFound":"Melanoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M19079", "ConditionBrowseLeafName":"Neuroendocrine Tumors", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18428", "ConditionBrowseLeafName":"Neuroectodermal Tumors", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18971", "ConditionBrowseLeafName":"Neuroectodermal Tumors, Primitive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10901", "ConditionBrowseLeafName":"Neoplasms, Germ Cell and Embryonal", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10908", "ConditionBrowseLeafName":"Neoplasms, Nerve Tissue", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11029", "ConditionBrowseLeafName":"Nevus", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11031", "ConditionBrowseLeafName":"Nevus, Pigmented", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M19054", "ConditionBrowseLeafName":"Nevi and Melanomas", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T3709", "ConditionBrowseLeafName":"Melanoma, Familial", "ConditionBrowseLeafAsFound":"Cutaneous Melanoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T4118", "ConditionBrowseLeafName":"Neuroendocrine Tumor", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4119", "ConditionBrowseLeafName":"Neuroepithelioma", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }