[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100360779":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":140,"collaborators":145,"id":147,"slug":26,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":26,"enrollmentInfo":156,"targetDuration":26,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Deferred nephrectomy","EXPERIMENTAL","Surgery after induction therapy with IO\u002FIO or a TKI\u002FIO-combination, followed by maintenance therapy with nivolumab or a TKI\u002FIO-combination.",[13,14],"Procedure: Cytoreductive nephrectomy","Other: Tissue sampling",{"label":16,"type":17,"description":18,"interventionNames":19},"No surgery","ACTIVE_COMPARATOR","Induction therapy wih IO\u002FIO or a TKI\u002FIO-combination, followed by maintenance therapy with nivolumab or a TKI\u002FIO-combination.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Cytoreductive nephrectomy","Partial or complete nephrectomy by open, laparoscopic, or robotic approach.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Tissue sampling","Tumor biopsies, blood, and stool specimens for translational biomarker research will be sampled at baseline and after 3 or 6 months.",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Niels Fristrup, MD PhD","Department of Oncology, Aarhus University Hospital.","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","004520914161","niels.fristrup@rm.dk",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Ane Iversen, MD PhD","ANEIVE@rm.dk",[45,60,76,92,107,126],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Department of Oncology, Aarhus University Hospital","RECRUITING","Aarhus","Central Region of Denmark","8200","Denmark",{"type":53,"coordinates":54},"Point",[55,56],10.21076,56.15674,{"lat":56,"lon":55},[59],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":61,"status":47,"city":62,"state":26,"zip":63,"country":51,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Department of Oncology, Herlev Hospital","Herlev","2730",{"type":53,"coordinates":65},[66,67],12.43998,55.72366,{"lat":67,"lon":66},[70,73],{"name":71,"role":38,"phone":26,"phoneExt":26,"email":72},"Anne Kirstine Moeller, MD, PhD","anne.kirstine.moeller.darras@regionh.dk",{"name":74,"role":38,"phone":26,"phoneExt":26,"email":75},"Jesper Palshof, MD PhD","Jesper.Andreas.Palshof@regionh.dk",{"facility":77,"status":47,"city":78,"state":26,"zip":79,"country":51,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Department of Oncology, Odense University Hospital","Odense","5000",{"type":53,"coordinates":81},[82,83],10.38831,55.39594,{"lat":83,"lon":82},[86,89],{"name":87,"role":38,"phone":26,"phoneExt":26,"email":88},"Jon R Henriksen, MD","Jon.Henriksen@rsyd.dk",{"name":90,"role":38,"phone":26,"phoneExt":26,"email":91},"Niels Viggo Jensen, MD","Niels.Viggo.Jensen@rsyd.dk",{"facility":93,"status":47,"city":94,"state":26,"zip":26,"country":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Department of Oncology, Ålesund Universitetsykehus","Ålesund","Norway",{"type":53,"coordinates":97},[98,99],6.15492,62.47225,{"lat":99,"lon":98},[102,105],{"name":103,"role":38,"phone":26,"phoneExt":26,"email":104},"Bjørg Y Aksnessæther, MD","bjorg.y.aksnessether@helse-mr.no",{"name":103,"role":106,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"facility":108,"status":47,"city":109,"state":26,"zip":26,"country":95,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Department of Urology, Haukeland University Hospital","Bergen",{"type":53,"coordinates":111},[112,113],5.32415,60.39299,{"lat":113,"lon":112},[116,120,124,125],{"name":117,"role":38,"phone":118,"phoneExt":26,"email":119},"Christian Beisland, Professor","0047 47301005","christian.beisland@helse-bergen.no",{"name":121,"role":38,"phone":122,"phoneExt":26,"email":123},"Karin Hjelle, MD","0047 92899241","karin.margrethe.hjelle@helse-bergen.no",{"name":117,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":121,"role":106,"phone":26,"phoneExt":26,"email":26},{"facility":127,"status":47,"city":128,"state":26,"zip":26,"country":95,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Department of Oncology, Stavanger Universitetssykehus","Stavanger",{"type":53,"coordinates":130},[131,132],5.73332,58.97005,{"lat":132,"lon":131},[135,139],{"name":136,"role":38,"phone":137,"phoneExt":26,"email":138},"Maria N Vigmostad, MD","0047 908 14 524","maria.nyre.vigmostad@sus.no",{"name":136,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":141,"investigatorFullName":142,"investigatorTitle":143,"investigatorAffiliation":144,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Niels Fristrup","MD PhD","Aarhus University Hospital",[146],{"name":144,"class":6},"100360779",false,"NCT03977571","Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial","Multicenter Randomized Trial of Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma Receiving Checkpoint Inhibitors: a Trial Evaluating the Impact of Surgery or No Surgery. The NORDIC-SUN-Trial","NORDIC-SUN","Inclusion Criteria:\n\n1. Signed written informed consent obtained prior to any study specific procedures.\n2. Patient must be willing and able to comply with the protocol.\n3. Age ≥18.\n4. Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.\n5. Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.\n6. Measurable disease as per RECIST v 1.1\n7. Patients for which Nivolumab\u002FIpilimumab or a TKI\u002FIO-combination is considered indicated according to the recommendations by the European Medicines Agency and the national health authorities of participating countries. The prescription of nivolumab\u002Fipilimumab or a TKI\u002FIO-combination in the circumstances of the study is considered as a standard treatment.\n8. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.\n9. Fertile women of childbearing potential (\\\u003C2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).\n10. Karnofsky Performance status ≥70\n11. Life expectancy of greater than 4 months.\n12. The required laboratory values are as follows:\n\n    * Adequate bone marrow function (Leucocytes \\> 3.0 x 109\u002Fl, platelets \\> 100 x 109\u002Fl, hemoglobin \\> 6.0 mmol\u002Fl or \\> 10.0 g\u002FdL.)\n    * International normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN)\n    * Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALAT ≤ 2.5 x ULN or ≤ 5 x ULN if liver lesions)\n    * Adequate kidney function (eGFR \\> 35 mL\u002Fmin)\n\nExclusion Criteria:\n\n1. Prior systemic treatment for mRCC\n2. Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).\n3. Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment\n4. Clinically significant (i.e active) cardiovascular disease for example cerebrovascular accidents (\\\u003C 6 months before inclusion), myocardial infarction (\\\u003C 6 months before inclusion), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure.\n5. No symptomatic brain metastasis requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent)\n6. Recent (within the 30 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.\n7. Any active or recent history of a known or suspected autoimmune disease or recent history of a condition that require systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications, excluding inhaled steroids and topical steroids. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, psoriasis not requiring systemic treatment are permitted to enroll.\n8. Known hypersensitivity to monoclonal antibodies.\n9. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n10. Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection.\n11. Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.","ALL","18 Years",{"count":157,"type":158},400,"ESTIMATED","INTERVENTIONAL",[161],"NA","BACKGROUND: For synchronous metastatic renal cell carcinoma (RCC), surgical resection of the primary tumor in the presence of distant metastases has been the standard of therapy for select patients followed by systemic therapy. In the era of TKIs two randomized trials, CARMENA and SURTIME, have questioned the role and timing of surgery in these patients, results point towards no surgery or a deferred approach.\n\nRATIONALE: The antitumor activity of immune checkpoint blockage (ICB) is more potent than other therapy in mRCC. The deferred cytoreductive nephrectomy approach ensures systemic therapy for all patients, avoid systemic treatment delay, and spare surgery in patients with progressive tumors. Current data only point towards a survival benefit for cytoreductive nephrectomy in intermediate risk patients, but not in poor risk patients\n\nHYPOTHESIS: Deferred cytoreductive nephrectomy after initial nivolumab combined with ipilimumab or a TKI\u002FIO-combination will improve OS in patients with synchronous metastatic RCC and ≤3 IMDC risk features\n\nThis is an open, randomized, multicenter comparison trial, designed to evaluate the effect of deferred cytoreductive nephrectomy compared with no surgery following initial nivolumab combined with ipilimumab or a TKI-combination, in mRCC patients with IMDC intermediate and poor risk.",[164,165,166],"Kidney Cancer","Renal Cell Carcinoma Metastatic","Synchronous Neoplasm",[168,169,170,171,172,173,174],"Cytoreduction Surgical Procedures","Nephrectomy","Ipilimumab","Nivolumab","Laboratory biomarker analysis","Gene Expression","Liquid Biopsy","2026-04-28",{"date":177,"type":178},"2026-05-04","ACTUAL",{"date":180,"type":178},"2020-07-06",{"date":182,"type":158},"2031-12-01",{"name":142,"class":6},6]