Study of Digital Symptom Monitoring During Cabozantinib and Nivolumab Treatment for Advanced Clear-cell Kidney Cancer

What this Trial Is About

Researchers are evaluating the effect of digital monitoring of self-reported symptoms on how treatment is managed in patients with advanced clear cell renal cell carcinoma RCC receiving cabozantinib plus nivolumab. This Phase 4 study focuses on the first three months of combined treatment in a real-life setting, aiming to improve patient care by adjusting treatments based on weekly symptom reports. The study is sponsored by Centre Francois Baclesse. Participants receive cabozantinib orally once daily and nivolumab intravenously every two weeks as prescribed in the labeling. During this treatment, a digital monitoring system collects weekly patient reports on treatment tolerance. The system uses an algorithm to classify patients risk levels and generate alerts that may lead to treatment adjustments. This digital telemonitoring platform supports early detection of adverse events related to the combination therapy. Participants will be involved in regular weekly self-reporting of symptoms through a mobile digital device for up to six months. Researchers will assess treatment management adjustments within the first three months and track symptom evolution, fatigue, quality of life, anxiety, depression, pain, and adverse reactions over six months. The study evaluates the feasibility of this digital approach to follow-up and the impact of alerts generated by the monitoring platform on patient management and outcomes.

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