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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 19 центров

• 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
• … и ещё 11 центров

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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