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

NCT07028125 | Recruiting Phase 4

• 1 other identifier: 2024-518991-30-00
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 16

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

Conditions

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

Keywords

kidney cancer; metastatic; cabozantinib; nivolumab; digital monitoring system

Outcome Measures

Primary Outcomes (1)

• 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

  within the first 3 months of the combined treatment (cabozantinib and nivolumab)

Secondary Outcomes (9)

• - The evolution of self-reported symptoms

  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

  during the first 3 months of the combination (cabozantinib and nivolumab)

• - To characterize and evaluate regular follow-up of patients self-reported fatigue

  During the first 6 months of combination (cabozantinib and nivolumab)

• - To have a longitudinal assessment of general health-related quality of life (QoL)

  During the first 6 months of combination (cabozantinib and nivolumab)

• - To assess the feasibility of regular follow-up of PROs in real life

  At 3 and 6 months after initiation of combination (cabozantinib and nivolumab)

Study Arms (1)

Digital monitoring under Cabozantinib and nivolumab treatments

EXPERIMENTAL

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

Interventions

cabozantinib and nivolumab 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.

Digital monitoring under Cabozantinib and nivolumab treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (16)

Centre Hospitalier d'Annecy

Annecy, France

NOT YET RECRUITING

Institut Sainte Catherine

Avignon, France

RECRUITING

Centre Hospitalier de Bayeux

Bayeux, France

NOT YET RECRUITING

CH Boulogne sur Mer

Boulogne-sur-Mer, France

NOT YET RECRUITING

Centre François Baclesse

Caen, France

RECRUITING

Polyclinique du Parc Elsan

Caen, France

NOT YET RECRUITING

Institut Andrée Dutreix

Coudekerque-Branche, France

NOT YET RECRUITING

Ghpso Creil

Creil, France

NOT YET RECRUITING

Centre Hospitalier de Lorient

Lorient, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, France

NOT YET RECRUITING

GHR Mulhouse Sud Alsace

Mulhouse, France

RECRUITING

Centre Antoine Lacassagne

Nice, France

NOT YET RECRUITING

CHU

Saint-Etienne, France

NOT YET RECRUITING

Hôpital FOCH

Suresnes, France

NOT YET RECRUITING

Centre Hospitalier de Tours

Tours, France

NOT YET RECRUITING

Centre d'oncologie St Yves

Vannes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Neoplasm Metastasis

Interventions

cabozantinib; Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Florence LOBBEDEZ

CONTACT

+33231455002; f.joly@baclesse.unicancer.fr

Romain LEVARD, MD

CONTACT

+33231455002; r.levard@baclesse.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)