[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587874":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":44,"responsibleParty":147,"collaborators":149,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":155,"sex":161,"minAge":162,"maxAge":38,"enrollmentInfo":163,"targetDuration":38,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":135,"whyStopped":38,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cabozantinib-Nivolumab","EXPERIMENTAL","The patient will be treated according to standard of care Nivolumab Cabozantinib.",[13,14],"Drug: Nivolumab","Drug: Cabozantinib",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Nivolumab","Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.",[9],[22],"OPDIVO",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Cabozantinib","Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg\u002Fday.",[9],[28],"CABOMETYX",[30],{"name":31,"affiliation":5,"role":32},"Maxime FRELAUT, MD","PRINCIPAL_INVESTIGATOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Maxime Frelaut, MD","CONTACT","+33 1 42 11 57 60",null,"Maxime.FRELAUT@gustaveroussy.fr",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Maia Claveau CLAVEAU","+33 1 42 11 53 49","maia.claveau@gustaveroussy.fr",[45,63,77,91,105,119,133],{"facility":46,"status":47,"city":48,"state":38,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Institut de Cancérologie de l'Ouest - 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Hôpital Bretonneau","Tours","37044",{"type":53,"coordinates":124},[125,126],0.70398,47.39484,{"lat":126,"lon":125},[129],{"name":130,"role":36,"phone":131,"phoneExt":38,"email":132},"Mathilde CANCEL, MD","+33 2 47 47 99 99","m.cancel@chu-tours.fr",{"facility":134,"status":135,"city":136,"state":38,"zip":137,"country":50,"countryCode":51,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Gustave Roussy","RECRUITING","Villejuif","94800",{"type":53,"coordinates":139},[140,141],2.35992,48.7939,{"lat":141,"lon":140},[144],{"name":31,"role":36,"phone":145,"phoneExt":38,"email":146},"+33 142115760","Maxime.frelaut@gustaveroussy.fr",{"type":148,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[150],{"name":151,"class":152},"Ipsen","INDUSTRY","100587874","phase-4-cabozantinib-and-nivolumab-among-older-patients-with-renal-cell-carcinoma-100587874",false,"NCT06934057","Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma","Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation","CABOLD","Inclusion Criteria:\n\n1. Patients ≥ 70 years-old\n2. Confirmed advanced or metastatic renal-cell carcinoma\n3. Patients not previously treated in metastatic setting\n4. Performance Status 0 to 2\n5. Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.\n6. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n7. Patients must be affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)\n2. Performance Status \\> 2\n3. Any condition that represent a contraindication to Cabozantinib and\u002For Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant\u002Fmodulator (thyroid or adrenal disorder are not an exclusion criteria)\n4. Any severe cardiovascular or thrombo-embolic event in the last three months\n5. Any situation for which exclusive palliative care intervention is recommended\n6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent","ALL","70 Years",{"count":164,"type":165},50,"ESTIMATED","INTERVENTIONAL",[168],"PHASE4","The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer",[171,172],"Kidney Cancer","Renal Cell Cancer",[174,175,176,177,178,179],"renal cell carcinoma","kidney cancer","cabozantinib","nivolumab","elderly patients","geriatric population","2025-09-23",{"date":182,"type":183},"2025-09-24","ACTUAL",{"date":185,"type":183},"2025-05-16",{"date":187,"type":165},"2028-04",{"name":5,"class":6},7]