Actively Recruiting
Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma
Led by Centre Francois Baclesse · Updated on 2025-10-07
83
Participants Needed
10
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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/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 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 during the study and 5 months after last dose
- Subject affiliated to an appropriate social security system
- Patient has signed informed consents obtained before any trial related activities and according to local guidelines
You will not qualify if you...
- 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 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
AI-Screening
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Trial Site Locations
Total: 10 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
Centre François Baclesse
Caen, France
Actively Recruiting
5
Polyclinique du Parc Elsan
Caen, France
Not Yet Recruiting
6
Ghpso Creil
Creil, France
Not Yet Recruiting
7
Centre Hospitalier de Lorient
Lorient, France
Not Yet Recruiting
8
GHR Mulhouse Sud Alsace
Mulhouse, France
Actively Recruiting
9
CHU
Saint-Etienne, France
Not Yet Recruiting
10
Centre Hospitalier de Tours
Tours, France
Not Yet Recruiting
Research Team
F
Florence LOBBEDEZ
CONTACT
R
Romain LEVARD, MD
CONTACT
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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