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

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 advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment

Eligibility

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

Conditions4

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