Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Centre Hospitalier d'Annecy
NOT_YET_RECRUITING
Annecy
Institut Sainte Catherine
RECRUITING
Avignon
Centre Hospitalier de Bayeux
NOT_YET_RECRUITING
Bayeux
Centre François Baclesse
RECRUITING
Caen
Polyclinique du Parc Elsan
NOT_YET_RECRUITING
Caen
Ghpso Creil
NOT_YET_RECRUITING
Creil
Centre Hospitalier de Lorient
NOT_YET_RECRUITING
Lorient
GHR Mulhouse Sud Alsace
RECRUITING
Mulhouse
CHU
NOT_YET_RECRUITING
Saint-etienne
Centre Hospitalier de Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Florence LOBBEDEZ
f.joly@baclesse.unicancer.fr
+33231455002
Backup
Romain LEVARD, MD
r.levard@baclesse.unicancer.fr
+33231455002
Time Frame
Start Date:2025-10-01
Estimated Completion Date:2029-01
Participants
Target number of participants:83
Treatments
Experimental: Digital monitoring under Cabozantinib and nivolumab treatments
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report.~The digital telemonitoring platform is used to facilitate the monitoring of signs and symptoms of treatment-specific Adverse Events.~The platform integrates an algorithm to define patient risk based on responses to data collected on platform.~The self-reported information on the mobile digital device allows to classify patients (correct, compromised, to be monitored, or critical) and to create some alerts.~Some actions may be undertaken depending on these alerts, with adjustments of the management of treatments