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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2029-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital monitoring under Cabozantinib and nivolumab treatments

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

Group Type EXPERIMENTAL

cabozantinib and nivolumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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