[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372244":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":37,"locations":44,"responsibleParty":58,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":42,"enrollmentInfo":76,"targetDuration":42,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":42,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tilsotolimod (IMO-2125)","EXPERIMENTAL","Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).",[13],"Drug: Tilsotolimod",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).",[19],"Drug: Saline (0.9% sodium chloride)",[21,27],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Tilsotolimod",[9],[26],"IMO-2125",{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"Saline (0.9% sodium chloride)",[15],[15],[32,35],{"name":33,"affiliation":5,"role":34},"Tanja de Gruijl","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Alfons JM van den Eertwegh",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Jessica CL Notohardjo, MD","CONTACT","+3120 4444881",null,"intrim@vumc.nl",[45],{"facility":46,"status":47,"city":48,"state":42,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":42},"VU Medical Centere","RECRUITING","Amsterdam","1081 HV","Netherlands","NL",{"type":53,"coordinates":54},"Point",[55,56],4.88969,52.37403,{"lat":56,"lon":55},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","A.J.M. van den Eertwegh","Principal Investigator",[63],{"name":64,"class":65},"Idera Pharmaceuticals, Inc.","INDUSTRY","100372244","phase-2-a-randomized-controlled-phase-ii-trial-with-intradermal-imo-2125-in-pathological-tumor-stage-p-t3-4-cn0m0-melanoma-100372244",false,"NCT04126876","A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma","A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma","INTRIM","Inclusion Criteria:\n\n* 18 years or older\n* Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth \\>2.0 mm\n* Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB)\n* World Health Organization (WHO) Performance Status ≤1\n* Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration\n* Written informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to any oligodeoxynucleotide\n* Active auto-immune disease requiring disease-modifying therapy at the tumr of screening\n* Pathologically confirmed loco-regional or distant metastasis\n* Non-skin melanoma\n* Patients with another primary malignancy (some exceptions)\n* Active systemic infections requiring antibiotics\n* Women who are pregnant or breast-feeding","ALL","18 Years",{"count":77,"type":78},214,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is",[84],"Malignant Melanoma","2021-04-14",{"date":87,"type":88},"2021-04-15","ACTUAL",{"date":90,"type":88},"2020-01-22",{"date":92,"type":78},"2031-11-01",{"name":60,"class":6},1]