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Recruiting Phase 4

Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma

NCT07028125 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2025-10-01
Last updated
2026-07-14

Condition(s) studied

Renal Cell Carcinoma (Kidney Cancer)Metastatic Renal Cell CarcinomaLocally Advanced

Investigational drug(s) / intervention(s)

cabozantinib and nivolumab

cabozantinib and nivolumab: cabozantinib and nivolumab according to the labelling indication, namely: * CABOZANTINIB 40 mg per oral route once daily * NIVOLUMAB 240 mg per intravenous route every 2 weeks During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient older than 18 years * Diagnosis of advanced/metastatic Renal Cell Carcinoma (RCC) with a clear-cell component * No prior systemic treatment for RCC * Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced/metastatic RCC, according to approved local labels * 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. * Subject affiliated to an appropriate social security system * Patient has signed informed consents obtained before any trial related activities and according to local guidelines Exclusion Criteria: * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol * Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study * Patient with history of allergy or hypersensitivity to components of the study drugs * Patient with contraindication to the study drugs * Pregnant or lactating woman * Patient unable to use digital tools * Patient deprived of liberty or placed under the authority of a tutor * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Primary outcome measure(s)

  • Rate of patients with adjustment of treatments management — within the first 3 months of the combined treatment (cabozantinib and nivolumab)
    rate of patients with adjustment of treatments management including any unplanned action guided by weekly digital monitoring of self-reported symptoms: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment

Trial sites (19)

FacilityCityRegionStatus
Centre Hospitalier d'Annecy Annecy France Not Yet Recruiting
Institut Sainte Catherine Avignon France Recruiting
Centre Hospitalier de Bayeux Bayeux France Not Yet Recruiting
CH Boulogne sur Mer Boulogne-sur-Mer France Not Yet Recruiting
Centre François Baclesse Caen France Recruiting
Polyclinique du Parc Elsan Caen France Not Yet Recruiting
Institut Andrée Dutreix Coudekerque-Branche France Not Yet Recruiting
Ghpso Creil Creil France Not Yet Recruiting
Institut de cancérologie de Bourgogne Dijon France Not Yet Recruiting
Centre Hospitalier de Lorient Lorient France Not Yet Recruiting
Centre Léon Bérard Lyon France Not Yet Recruiting
Chu Montpellier Montpellier France Not Yet Recruiting
GHR Mulhouse Sud Alsace Mulhouse France Recruiting
Centre Antoine Lacassagne Nice France Not Yet Recruiting
Chu Poitiers Poitiers France Not Yet Recruiting
CHU Saint-Etienne France Not Yet Recruiting
Hôpital FOCH Suresnes France Not Yet Recruiting
Centre Hospitalier de Tours Tours France Not Yet Recruiting
Centre d'oncologie St Yves Vannes France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07028125 on ClinicalTrials.gov ↗ ← All trials in France