RecruitingPhase 4NCT07028125

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

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

Sponsor

Centre Francois Baclesse

Enrollment

83 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Renal Cell Carcinoma Locally Advanced Renal Cell Carcinoma (Kidney Cancer)

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria8

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

Interventions

DRUGcabozantinib 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.