A Phase 4 interventional study of cabozantinib and nivolumab in Renal Cell Carcinoma (Kidney Cancer), Metastatic Renal Cell Carcinoma and Locally Advanced, sponsored by Centre Francois Baclesse. Recruiting at 19 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Centre Francois Baclesse · Phase 4, Interventional, and Treatment
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
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.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 83 is above the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Centre Francois Baclesse is the lead sponsor of 110 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: cabozantinib 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.
This study also gives Nivolumab, Cabozantinib. No intervention listed here names it: that was found by reading the record.
Rate of patients with adjustment of treatments management
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
Time frame: within the first 3 months of the combined treatment (cabozantinib and nivolumab)
- The evolution of self-reported symptoms
report regular follow-up of self-reported symptoms on the digital platform
Time frame: during the first 6 months of the combination (cabozantinb and nivolumab)
- To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment
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
Time frame: during the first 3 months of the combination (cabozantinib and nivolumab)
- To characterize and evaluate regular follow-up of patients self-reported fatigue
Score of self-reported fatigue by the questionnaire Facit-F (score between 0 and 160)
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
- To have a longitudinal assessment of general health-related quality of life (QoL)
\- The evolution of general health-related quality of life with the score of FSKI-10 questionnaire (score between 0 and 40)
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
- To assess the feasibility of regular follow-up of PROs in real life
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)
Time frame: At 3 and 6 months after initiation of combination (cabozantinib and nivolumab)
- To characterize and describe warning adverse reactions
\- The characterization and description of warning adverse reactions that may require therapeutic adaptation
Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)
- To characterize alerts issued by digital monitoring
Follow-up of number of alerts issued by digital monitoring
Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)
To have a longitudinal assessment of anxiety/depression and pain
The evolution of anxiety/depression with HADS scale (score between 0 and 56)
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
To characterize alerts issued by digital monitoring
Follow-up on the type of alerts (dose adjustment or treatment discontinuation)
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
Plan to share: No
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