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

Official title

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

Overview

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

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 tolerance, based on patient reports.

Interventions

• Drug 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.

Primary outcome measures

• Rate of patients with adjustment of treatments management [Time frame: within the first 3 months of the combined treatment (cabozantinib and nivolumab)]

Secondary outcome measures (9)

• - The evolution of self-reported symptoms [Time frame: 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 [Time frame: during the first 3 months of the combination (cabozantinib and nivolumab)]
• - To characterize and evaluate regular follow-up of patients self-reported fatigue [Time frame: During the first 6 months of combination (cabozantinib and nivolumab)]
• - To have a longitudinal assessment of general health-related quality of life (QoL) [Time frame: During the first 6 months of combination (cabozantinib and nivolumab)]
• - To assess the feasibility of regular follow-up of PROs in real life [Time frame: At 3 and 6 months after initiation of combination (cabozantinib and nivolumab)]
• - To characterize and describe warning adverse reactions [Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)]
• - To characterize alerts issued by digital monitoring [Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)]
• To have a longitudinal assessment of anxiety/depression and pain [Time frame: During the first 6 months of combination (cabozantinib and nivolumab)]
• To characterize alerts issued by digital monitoring [Time frame: During the first 6 months of combination (cabozantinib and nivolumab)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 19 centers

• Centre Hospitalier d'Annecy — Annecy
• Institut Sainte Catherine — Avignon
• Centre Hospitalier de Bayeux — Bayeux
• CH Boulogne sur Mer — Boulogne-sur-Mer
• Centre François Baclesse — Caen
• Polyclinique du Parc Elsan — Caen
• Institut Andrée Dutreix — Coudekerque-Branche
• Ghpso Creil — Creil
• … and 11 more centers

Identifiers

NCT: NCT07028125 · 2024-518991-30-00 · 2024-518991-30-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗