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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Patients receive the combination of Cabozantinib and Nivolumab as indicated in the label. During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance, based on patient reports.

Conditions

• Renal Cell Carcinoma (Kidney Cancer)
• Metastatic Renal Cell Carcinoma
• Locally Advanced

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-10-01
• Completion: 2029-01-01
• First posted: 2025-06-19
• Last updated: 2025-10-07

Locations

10 sites across 1 country: France