[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595105":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":254,"collaborators":20,"id":256,"slug":257,"hasResults":258,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":258,"sex":264,"minAge":265,"maxAge":20,"enrollmentInfo":266,"targetDuration":20,"studyType":269,"phases":270,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital monitoring under Cabozantinib and nivolumab treatments","EXPERIMENTAL","During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report.\n\nThe digital telemonitoring platform is used to facilitate the monitoring of signs and symptoms of treatment-specific Adverse Events.\n\nThe platform integrates an algorithm to define patient risk based on responses to data collected on platform.\n\nThe self-reported information on the mobile digital device allows to \"classify\" patients (\"correct\", \"compromised\", \"to be monitored\", or \"critical) and to create some alerts.\n\nSome actions may be undertaken depending on these alerts, with adjustments of the management of treatments",[13],"Drug: cabozantinib and nivolumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","cabozantinib and nivolumab","cabozantinib and nivolumab according to the labelling indication, namely:\n\n* CABOZANTINIB 40 mg per oral route once daily\n* NIVOLUMAB 240 mg per intravenous route every 2 weeks\n\nDuring this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Florence LOBBEDEZ","CONTACT","+33231455002","f.joly@baclesse.unicancer.fr",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Romain LEVARD, MD","r.levard@baclesse.unicancer.fr",[31,48,65,80,93,105,116,129,144,158,171,186,199,214,227,241],{"facility":32,"status":33,"city":34,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Centre Hospitalier d'Annecy","NOT_YET_RECRUITING","Annecy","France","FR",{"type":38,"coordinates":39},"Point",[40,41],6.12565,45.90878,{"lat":41,"lon":40},[44],{"name":45,"role":24,"phone":46,"phoneExt":20,"email":47},"Mélodie CARBONNAUX","33450636978","mcarbonnaux@ch-annecygenevois.fr",{"facility":49,"status":50,"city":51,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Institut 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CAROLA","33344616315","elisabeth.carola@ghpso.fr",{"name":143,"role":64,"phone":20,"phoneExt":20,"email":20},"CAROLA",{"facility":145,"status":33,"city":146,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Centre Hospitalier de Lorient","Lorient",{"type":38,"coordinates":148},[149,150],-3.37177,47.74817,{"lat":150,"lon":149},[153,157],{"name":154,"role":24,"phone":155,"phoneExt":20,"email":156},"Marie L'HUISSIER","33297069694","m.lhuissier@ghbs.bzh",{"name":154,"role":64,"phone":20,"phoneExt":20,"email":20},{"facility":159,"status":33,"city":160,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Centre Léon Bérard","Lyon",{"type":38,"coordinates":162},[163,164],4.84789,45.74906,{"lat":164,"lon":163},[167],{"name":168,"role":24,"phone":169,"phoneExt":20,"email":170},"VINCENEUX","+33 (0)4 26 55 68 42","Armelle.VINCENEUX@lyon.unicancer.fr",{"facility":172,"status":50,"city":173,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"GHR Mulhouse Sud Alsace","Mulhouse",{"type":38,"coordinates":175},[176,177],7.32866,47.75205,{"lat":177,"lon":176},[180,184],{"name":181,"role":24,"phone":182,"phoneExt":20,"email":183},"Amina TABET","33389647513","amina.tabet-zatla@ghrmsa.fr",{"name":185,"role":64,"phone":20,"phoneExt":20,"email":20},"TABET",{"facility":187,"status":33,"city":188,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Centre Antoine Lacassagne","Nice",{"type":38,"coordinates":190},[191,192],7.26608,43.70313,{"lat":192,"lon":191},[195],{"name":196,"role":24,"phone":197,"phoneExt":20,"email":198},"Nicolas MARTIN, MD","0492031000","nicolas.martin@nice.unicancer.fr",{"facility":200,"status":33,"city":201,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"CHU","Saint-Etienne",{"type":38,"coordinates":203},[204,205],4.39,45.43389,{"lat":205,"lon":204},[208,212],{"name":209,"role":24,"phone":210,"phoneExt":20,"email":211},"Pierre CORNILLON","33477822443","pierre.cornillon@chu-st-etienne.fr",{"name":213,"role":64,"phone":20,"phoneExt":20,"email":20},"CORNILLON",{"facility":215,"status":33,"city":216,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Hôpital FOCH","Suresnes",{"type":38,"coordinates":218},[219,220],2.22929,48.87143,{"lat":220,"lon":219},[223],{"name":224,"role":24,"phone":225,"phoneExt":20,"email":226},"VANO","+33 (0)1 46 25 20 78","y.vano@hopital-foch.com",{"facility":228,"status":33,"city":229,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Centre Hospitalier de Tours","Tours",{"type":38,"coordinates":231},[232,233],0.70398,47.39484,{"lat":233,"lon":232},[236,239],{"name":237,"role":24,"phone":238,"phoneExt":20,"email":20},"Mathilde CANCEL","33218370871",{"name":240,"role":64,"phone":20,"phoneExt":20,"email":20},"CANCEL",{"facility":242,"status":33,"city":243,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Centre d'oncologie St Yves","Vannes",{"type":38,"coordinates":245},[246,247],-2.76205,47.65688,{"lat":247,"lon":246},[250],{"name":251,"role":24,"phone":252,"phoneExt":20,"email":253},"Victor BASSE","0297625534","vbasse@centre-st-yves.fr",{"type":255,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100595105","phase-4-digital-monitoring-of-self-reported-symptoms-by-patients-treated-with-cabozantinib-plus-nivolumab-for-advanced-clear-cell-renal-carcinoma-100595105",false,"NCT07028125","Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma","Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study","CANIQOL","Inclusion Criteria:\n\n* Patient older than 18 years\n* Diagnosis of advanced\u002Fmetastatic Renal Cell Carcinoma (RCC) with a clear-cell component\n* No prior systemic treatment for RCC\n* Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced\u002Fmetastatic RCC, according to approved local labels\n* Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used.\n* Subject affiliated to an appropriate social security system\n* Patient has signed informed consents obtained before any trial related activities and according to local guidelines\n\nExclusion Criteria:\n\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Current participation in another clinical study and\u002For in an investigational program with any intervention that could possibly interfere with the treatment and impact this study\n* Patient with history of allergy or hypersensitivity to components of the study drugs\n* Patient with contraindication to the study drugs\n* Pregnant or lactating woman\n* Patient unable to use digital tools\n* Patient deprived of liberty or placed under the authority of a tutor\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol","ALL","18 Years",{"count":267,"type":268},83,"ESTIMATED","INTERVENTIONAL",[271],"PHASE4","The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment",[274,275,276],"Renal Cell Carcinoma (Kidney Cancer)","Metastatic Renal Cell Carcinoma","Locally Advanced",[278,279,280,281,282],"kidney cancer","metastatic","cabozantinib","nivolumab","digital monitoring system","2026-06-04",{"date":285,"type":286},"2026-06-05","ACTUAL",{"date":288,"type":286},"2025-10-01",{"date":290,"type":268},"2029-01",{"name":5,"class":6},16]