Locally Advanced, Metastatic Renal Cell Carcinoma, Renal Cell Carcinoma (Kidney Cancer)
Conditions
Keywords
kidney cancer, metastatic, cabozantinib, nivolumab, digital monitoring system
Brief 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.
Interventions
DRUGcabozantinib 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.
Sponsors
Centre Francois Baclesse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - The evolution of self-reported symptoms | during the first 6 months of the combination (cabozantinb and nivolumab) | 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 | during the first 3 months of the combination (cabozantinib and nivolumab) | 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 | During the first 6 months of combination (cabozantinib and nivolumab) | 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) | During the first 6 months of combination (cabozantinib and nivolumab) | \- The evolution of general health-related quality of life with the score of FSKI-10 questionnaire (score between 0 and 40) |
| - To assess the feasibility of regular follow-up of PROs in real life | At 3 and 6 months after initiation of combination (cabozantinib and nivolumab) | The levels of satisfaction and difficulties encountered by patients using the digital monitoring with the French validated version of the self-questionnaire F-SUS System Usability Scale (score between 0 and 50) |
| - To characterize and describe warning adverse reactions | During the first 6 months of the combination (cabozantinib and nivolumab) | \- The characterization and description of warning adverse reactions that may require therapeutic adaptation |
| - To characterize alerts issued by digital monitoring | During the first 6 months of the combination (cabozantinib and nivolumab) | Follow-up of number of alerts issued by digital monitoring |
| To have a longitudinal assessment of anxiety/depression and pain | During the first 6 months of combination (cabozantinib and nivolumab) | The evolution of anxiety/depression with HADS scale (score between 0 and 56) |
| To characterize alerts issued by digital monitoring | During the first 6 months of combination (cabozantinib and nivolumab) | Follow-up on the type of alerts (dose adjustment or treatment discontinuation) |
Countries
France
Contacts
CONTACTFlorence LOBBEDEZ
CONTACTRomain LEVARD, MD
Outcome results
None listed