[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646205":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":96,"collaborators":24,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":24,"enrollmentInfo":108,"targetDuration":24,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":75,"whyStopped":24,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A: early morning immunotherapy","ACTIVE_COMPARATOR","Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting before 10am",[13],"Other: Timing of first administration (early morning)",{"label":15,"type":10,"description":16,"interventionNames":17},"B: afternoon immunotherapy","Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting after 1pm",[18],"Other: Timing of immunotherapy (afternoon)",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Timing of first administration (early morning)","The timing of the first administration of combination immunotherapy starting before 10am",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Timing of immunotherapy (afternoon)","The timing of the first administration of combination immunotherapy starting after 1pm",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Kalijn Bol, MD\u002FPhD","CONTACT","+31243618800","kalijn.bol@radboudumc.nl",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":37},"Mirte Meijerink","studies.onco@radboudumc.nl",[39,54,62,73,85],{"facility":40,"status":41,"city":42,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Amsterdam UMC","NOT_YET_RECRUITING","Amsterdam","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.88969,52.37403,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":24,"phoneExt":24,"email":24},"Fons van den Eertwegh",{"facility":55,"status":41,"city":42,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Antoni van Leeuwenhoek",{"type":46,"coordinates":57},[48,49],{"lat":49,"lon":48},[60],{"name":61,"role":32,"phone":24,"phoneExt":24,"email":24},"Hans van Thienen",{"facility":63,"status":41,"city":64,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Leiden UMC","Leiden",{"type":46,"coordinates":66},[67,68],4.49306,52.15833,{"lat":68,"lon":67},[71],{"name":72,"role":32,"phone":24,"phoneExt":24,"email":24},"Ellen Kapiteijn",{"facility":74,"status":75,"city":76,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Radboudumc","RECRUITING","Nijmegen",{"type":46,"coordinates":78},[79,80],5.85278,51.8425,{"lat":80,"lon":79},[83,84],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},{"name":36,"role":32,"phone":24,"phoneExt":24,"email":37},{"facility":86,"status":41,"city":87,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"ErasmusMC","Rotterdam",{"type":46,"coordinates":89},[90,91],4.47917,51.9225,{"lat":91,"lon":90},[94],{"name":95,"role":32,"phone":24,"phoneExt":24,"email":24},"Astrid van der Veldt",{"type":97,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100646205","timing-of-immunotherapy-in-melanoma-100646205",false,"NCT07696715","Timing of Immunotherapy in Melanoma","Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm","TIME-NL","Inclusion Criteria:\n\n* Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease.\n* At least 18 years of age.\n* World Health Organization (WHO) Performance Status 0-1.\n* Measurable disease according to RECIST 1.1.\n* Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment.\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Uveal or mucosal melanoma (unknown primary melanoma is allowed).\n* Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.\n* Use of adrenal replacement medications, e.g. hydrocortisone.\n* Use of melatonin agonists.\n* Prior systemic therapy for irresectable\u002Fmetastatic melanoma (prior T-VEC is allowed)\n* Prior systemic therapy for resectable melanoma in the last 6 months (neo-adjuvant and adjuvant treatment is allowed if at least 6 months ago).\n* Use of investigational drugs.","ALL","18 Years",{"count":109,"type":110},170,"ESTIMATED","INTERVENTIONAL",[113],"NA","The TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data from the randomized clinical trial will be combined with observational data.",[116],"Melanoma",[118,119,120],"melanoma","chronoimmunotherapy","timing","2026-08-12",{"date":123,"type":124},"2026-08-13","ACTUAL",{"date":126,"type":124},"2026-08-10",{"date":128,"type":110},"2033-09-30",{"name":5,"class":6},5]