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

Phase 4

Recruiting

• Conditions: Renal Cell Carcinoma (Kidney Cancer); Metastatic Renal Cell Carcinoma; Locally Advanced
• Interventions: Drug: cabozantinib and nivolumab

• Registration Number: NCT07028125
• Lead Sponsor: Centre Francois Baclesse

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.

Study Timeline

• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-17
• Study First Posted: 2025-06-19
• Status Verified: 2025-10
• Study Start: 2025-10-01
• Last Update Submitted: 2025-10-02
• Last Update Posted: 2025-10-07
• Primary Completion: 2028-10
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital monitoring under Cabozantinib and nivolumab treatments	cabozantinib and nivolumab	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- 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)

Trial Locations

Locations (10)

Centre Hospitalier d'Annecy; 🇫🇷 Annecy, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier de Bayeux; 🇫🇷 Bayeux, France

Centre François Baclesse; 🇫🇷 Caen, France

Polyclinique du Parc Elsan; 🇫🇷 Caen, France

Ghpso Creil; 🇫🇷 Creil, France

Centre Hospitalier de Lorient; 🇫🇷 Lorient, France

GHR Mulhouse Sud Alsace; 🇫🇷 Mulhouse, France

CHU; 🇫🇷 Saint-Etienne, France

Centre Hospitalier de Tours; 🇫🇷 Tours, France