Actively Recruiting
Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study
Led by Centre Francois Baclesse · Updated on 2026-06-05
83
Participants Needed
16
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how digital monitoring of patient-reported symptoms affects treatment management in people receiving cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC). The study focuses on the first three months of combined treatment and is conducted in real-life settings to understand treatment tolerance and adjustments. Participants receive cabozantinib orally once daily at 40 mg and nivolumab intravenously every two weeks as per approved labels. Throughout this combined treatment, a digital telemonitoring system collects weekly self-reports of symptoms and treatment side effects. The system uses an algorithm to classify patients by risk level and generate alerts, which may lead to treatment adjustments during the study. During participation, patients regularly report symptoms using a mobile device, allowing researchers to track treatment tolerance, symptom changes, fatigue, quality of life, anxiety, and pain over six months. The primary outcome is the rate of treatment management adjustments within the first three months. The study also evaluates the feasibility of digital symptom monitoring and the nature of alerts issued, ensuring ongoing safety and quality of care.
CONDITIONS
Brief Title
Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 18 years
- Diagnosis of advanced or metastatic renal cell carcinoma with a clear-cell component
- No prior systemic treatment for renal cell carcinoma
- Physician decision to treat with cabozantinib and nivolumab combination in first line
- Female patients of childbearing potential must not be pregnant and must use effective contraception during and 5 months after treatment
- Subject affiliated to an appropriate social security system
- Signed informed consent obtained before any trial activities
You will not qualify if you...
- Unable or unwilling to comply with study requirements
- Current participation in another clinical study or investigational program that interferes with treatment
- History of allergy or hypersensitivity to study drugs
- Contraindication to cabozantinib or nivolumab
- Pregnant or lactating women
- Unable to use digital tools
- Deprived of liberty or under tutor authority
- Investigator assessment of inability or unwillingness to comply with protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive the combination of cabozantinib orally once daily and nivolumab intravenously every 2 weeks. During this time, participants use a digital monitoring system to report symptoms weekly, which helps track treatment tolerance and manage treatment adjustments.
Weekly digital symptom reporting and regular intravenous nivolumab infusions every 2 weeks
Trial Site Locations
Total: 16 locations
1
Centre Hospitalier d'Annecy
Annecy, France
Not Yet Recruiting
2
Institut Sainte Catherine
Avignon, France
Actively Recruiting
3
Centre Hospitalier de Bayeux
Bayeux, France
Not Yet Recruiting
4
CH Boulogne sur Mer
Boulogne-sur-Mer, France
Not Yet Recruiting
5
Centre François Baclesse
Caen, France
Actively Recruiting
6
Polyclinique du Parc Elsan
Caen, France
Not Yet Recruiting
7
Institut Andrée Dutreix
Coudekerque-Branche, France
Not Yet Recruiting
8
Ghpso Creil
Creil, France
Not Yet Recruiting
9
Centre Hospitalier de Lorient
Lorient, France
Not Yet Recruiting
10
Centre Léon Bérard
Lyon, France
Not Yet Recruiting
11
GHR Mulhouse Sud Alsace
Mulhouse, France
Actively Recruiting
12
Centre Antoine Lacassagne
Nice, France
Not Yet Recruiting
13
CHU
Saint-Etienne, France
Not Yet Recruiting
14
Hôpital FOCH
Suresnes, France
Not Yet Recruiting
15
Centre Hospitalier de Tours
Tours, France
Not Yet Recruiting
16
Centre d'oncologie St Yves
Vannes, France
Not Yet Recruiting
Research Team
F
Florence LOBBEDEZ
R
Romain LEVARD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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