[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610906":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":25,"responsibleParty":45,"collaborators":25,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":25,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":25},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Upfront Cytoreductive Nephrectomy (CN)","EXPERIMENTAL","Participants will undergo immediate cytoreductive nephrectomy. About 4 weeks after surgery, they will receive induction therapy with ipilimumab plus nivolumab for 4 cycles, followed by maintenance nivolumab. Regular assessments of progression, perioperative complications, safety, and quality of life will be performed for 15 months.",[13,14],"Drug: Ipilimumab plus Nivolumab","Procedure: Cytoreductive Nephrectomy",{"label":16,"type":10,"description":17,"interventionNames":18},"Deferred Cytoreductive Nephrectomy (CN)","Participants will first receive 4 cycles of ipilimumab plus nivolumab induction therapy. After reassessment, they will undergo deferred cytoreductive nephrectomy, followed by maintenance nivolumab. Safety, perioperative complications, progression, and quality of life will be evaluated regularly for 15 months",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ipilimumab plus Nivolumab","Participants will receive 4 cycles of ipilimumab combined with nivolumab as induction therapy, followed by nivolumab maintenance depending on randomization schedule (before or after surgery).",[16,9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Cytoreductive Nephrectomy","Surgical removal of the primary kidney tumor (cytoreductive nephrectomy), performed either upfront (before systemic therapy) or deferred (after 4 cycles of ipilimumab\u002Fnivolumab induction), depending on randomization arm.",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Chang Wook Jeong, MD, PhD","Seoul National Universtiy Hospital","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":25,"email":40},"CONTACT","+82-2-2072-3899","drboss@snu.ac.kr",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Jang Hee Han, MD, PhD","+82-2-2072-1486","urohan@snu.ac.kr",{"type":35,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Chang Wook Jeong","Professor","100610906","immediate-versus-deferred-cytoreductive-nephrectomy-with-ipilimumabnivolumab-in-mrcc-100610906",false,"NCT07233668","Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab\u002FNivolumab in mRCC","Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab\u002FNivolumab in Metastatic Clear Cell Renal Cell Carcinoma: A Multicenter, Randomized, Open-Label, Phase III Trial","IVE in mRCC","Inclusion Criteria:\n\n* Participants must meet all of the following:\n* Age ≥ 19 years (male or female).\n* Histologically confirmed synchronous metastatic clear cell renal cell carcinoma.\n* ECOG performance status 0-1.\n* At least one measurable metastatic lesion (per RECIST v1.1).\n* Primary renal tumor considered surgically resectable.\n* IMDC intermediate- or poor-risk classification.\n* Estimated life expectancy \\> 3 months.\n* Ability to understand and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy for metastatic RCC.\n* History of another malignancy diagnosed or treated within 2 years (except for cured non-melanoma skin cancer or in-situ cancers).\n* Significant comorbid conditions making participation inappropriate, such as:\n\nModerate to severe cardiovascular, cerebrovascular, pulmonary, or hepatic disease.\n\n* History or suspicion of autoimmune disease incompatible with immune checkpoint inhibitor therapy.\n* Requirement for systemic corticosteroid therapy \\>10 mg\u002Fday prednisone equivalent, or other immunosuppressive drugs.\n* Any other condition judged by the investigator to make the patient unsuitable for trial participation.","ALL","19 Years",{"count":59,"type":60},172,"ESTIMATED","INTERVENTIONAL",[63],"NA","The goal of this clinical trial is to learn whether the timing of surgery (cytoreductive nephrectomy) improves outcomes when combined with immunotherapy (ipilimumab and nivolumab) in adults with metastatic clear cell renal cell carcinoma.\n\nThe main questions this study aims to answer are:\n\n* Does upfront (immediate) surgery before immunotherapy improve survival compared to delayed surgery after immunotherapy?\n* What medical problems (side effects or complications) occur with each treatment sequence?\n* How do the two strategies affect quality of life?\n\nResearchers will compare two groups:\n\n* Upfront surgery group: Participants will have surgery first, then receive 4 cycles of ipilimumab\u002Fnivolumab, followed by nivolumab maintenance.\n* Deferred surgery group: Participants will receive 4 cycles of ipilimumab\u002Fnivolumab first, then surgery, followed by nivolumab maintenance.\n\nParticipants will:\n\n* Be randomly assigned to one of the two groups\n* Undergo regular clinic visits, imaging tests, and blood collections for safety and biomarker studies\n* Be followed for 15 months to check disease progression, complications, survival, and quality of life\n\nThis trial will help determine the best timing for surgery in the era of immunotherapy and provide evidence for improved treatment strategies for patients with metastatic kidney cancer",[66],"Metastatic Renal Cell Carcinoma ( mRCC)",[68,69,28,70,71],"Metastatic Renal Cell Carcinoma","Immune Checkpoint Inhibitor","Progression-Free Survival","Randomized Clinical Trial","NOT_YET_RECRUITING","2025-11-25",{"date":75,"type":76},"2025-12-03","ACTUAL",{"date":78,"type":60},"2025-12-01",{"date":80,"type":60},"2029-02-01",{"name":5,"class":6}]