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
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
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
Single group
cabozantinib and nivolumab
Drugcabozantinib 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.
Rate of patients with adjustment of treatments management
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
- The evolution of self-reported symptoms
report regular follow-up of self-reported symptoms on the digital platform
- To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment
Follow-up of number of grade 3-4 of self-reported symptoms after modification of treatment management induced by remote follow-up at 3 months
- To characterize and evaluate regular follow-up of patients self-reported fatigue
Score of self-reported fatigue by the questionnaire Facit-F (score between 0 and 160)
- To have a longitudinal assessment of general health-related quality of life (QoL)
\- The evolution of general health-related quality of life with the score of FSKI-10 questionnaire (score between 0 and 40)
Click on the lead sponsor to view all of their trials.
