[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"A.J.M. van den Eertwegh\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":20,"type":21},214,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Malignant Melanoma","RECRUITING","2021-04-14",{"date":31,"type":32},"2021-04-15","ACTUAL",{"date":34,"type":32},"2020-01-22",{"date":36,"type":21},"2031-11-01",{"name":38,"class":39},"A.J.M. van den Eertwegh","OTHER",""]