Status:
RECRUITING
Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Renal Cell Carcinoma (Kidney Cancer)
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 tol...
Eligibility Criteria
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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT07028125
Start Date
October 1 2025
End Date
January 1 2029
Last Update
October 7 2025
Active Locations (10)
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1
Centre Hospitalier d'Annecy
Annecy, France
2
Institut Sainte Catherine
Avignon, France
3
Centre Hospitalier de Bayeux
Bayeux, France
4
Centre François Baclesse
Caen, France