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

Sponsor
Centre Francois Baclesse
Study ID
NCT07028125
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cabozantinib and nivolumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Oct 1, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
83 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Digital monitoring under Cabozantinib and nivolumab treatments
    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 Measure

Rate of patients with adjustment of treatments management [ Time Frame: within the first 3 months of the combined treatment (cabozantinib and nivolumab) ]

Central Contacts

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