[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synchronous-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synchronous-neoplasm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100360779","deferred-cytoreductive-nephrectomy-in-synchronous-metastatic-renal-cell-carcinoma-the-nordic-sun-trial-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":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Kidney Cancer","Renal Cell Carcinoma Metastatic","Synchronous Neoplasm",[31,32,33,34,35,36,37],"Cytoreduction Surgical Procedures","Nephrectomy","Ipilimumab","Nivolumab","Laboratory biomarker analysis","Gene Expression","Liquid Biopsy","RECRUITING","2026-04-28",{"date":41,"type":42},"2026-05-04","ACTUAL",{"date":44,"type":42},"2020-07-06",{"date":46,"type":21},"2031-12-01",{"name":48,"class":49},"Niels Fristrup","OTHER",6,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100497176","the-role-of-cytoreductive-nephrectomy-in-metastatic-renal-cell-carcinoma-in-immuno-oncology-era-sevuro-cn-trial-100497176","NCT05753839","The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial","SEVURO-CN","Inclusion Criteria:\n\n1. Core needle biopsy proven metastatic renal cell carcinoma - clear cell histologic subtypes only acceptable.\n2. Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.\n3. Patient must be willing to provide their human-derived materials.\n4. Age ≥19.\n5. Signed written informed consent obtained prior to any study specific procedures.\n6. Patient must be willing and able to comply with the protocol.\n7. Measurable disease as per RECIST v 1.1\n8. Life expectancy of greater than 4 months.\n9. Patients with more than one prognostic factor by the International Metastatic RCC Database Consortium (IMDC) criteria (intermediate- or poor-risk group).\n10. Patients for which Nivolumab\u002FIpilimumab considered indicated according to the recommendations by the national health authorities. The prescription of nivolumab\u002Fipilimumab in the circumstances of the study is considered as a standard treatment.\n11. Karnofsky Performance status ≥70\n12. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.\n13. 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).\n14. The required laboratory values are as follows:\n\n    * Adequate bone marrow function (Absolute neutrophil count \\> 1500\u002Fmm3, platelets \\> 100 x 103\u002Fµl, hemoglobin \\> 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)\n    * Adequate kidney function (eGFR \\> 35 mL\u002Fmin)\n\nExclusion Criteria:\n\n1. Prior systemic treatment for mRCC\n2. Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment\n3. Other cancer within 5 years.\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. Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.\n9. Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection.\n10. Known hypersensitivity to monoclonal antibodies.\n11. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n12. Patients disagreeing to provide their human-derived materials.\n13. Patients not willing and able to comply with the protocol.\n14. Vulnerable subjects (such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).\n15. Patients who cannot read and understand the consent form. (illiterate, foreigners, etc.)",{"count":59,"type":21},40,[24],"BACKGROUND: The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) has been questioned and remains undetermined in the immuno-oncology era. Results from the two randomized trials, CARMENA and SURTIME, have questioned the role and timing of the surgery in these patients, however, these trials have only used the targeted therapy, sunitinib. With the advent of more effective systemic therapies including immune checkpoint inhibitors (ICIs), the role of surgical therapy should be reexamined.\n\nRATIONALE: The therapeutic effects of ICIs have demonstrated improved oncological outcomes compared to sunitinib. The updated results reported the beneficial role of upfront and deferred CN approach for selected patients. No studies have formally investigated the role of CN in the immune-oncology era where combinatorial use of CN plus ICIs might be beneficial.\n\nHYPOTHESIS: Upfront or deferred CN will improve oncological outcomes (overall survival, and progression free survival) in patients with synchronous mRCC and ≤3 IMDC risk features compared to immune checkpoint inhibitors (nivolumab plus ipilimumab combination) alone.\n\nThis is an open, randomized, multicenter comparison trial, designed to evaluate the effect of the potential role of CN in combination with immunotherapy in mRCC patients with IMDC intermediate and poor risk.",[27,63,29],"Clear Cell Renal Cell Carcinoma Metastatic","2023-06-19",{"date":66,"type":42},"2023-06-22",{"date":68,"type":21},"2023-07",{"date":70,"type":21},"2031-12-31",{"name":72,"class":49},"Yonsei University",3]