Impact of Telemonitoring for the Management of Side Effects in Patients with Melanoma, Lung or Renal Cancer, Treated with Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy

Обзор

The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial. The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.

Вмешательства

• Поведенческое Tele-monitoring
  The tele-monitoring will consist in filling in a specific questionnaire once a week in the first 6 months, every 2 weeks until 12 months, and on-demand (in case of upcoming toxicity, at any time). These questionnaires will be reviewed by a coordinating nurse. According to the result of the questionnaire, the coordinating nurse will adapt patients' management, either by giving them a phone call, or inviting them to directly contact their medical department, or even plan an emergency hospitalizati

Первичные конечные точки

• Delay between the start of a side effect and reporting to the medical team (average number of days per patient). [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Levels of morbidity based on CTC-AE v5 (all toxicities) [Срок оценки: 12 months]
• Number of treatment interruptions and number of days of treatment delays interruptions, number of treatment discontinuation, number of dose reductions and and percentage of dose reduction [Срок оценки: 12 months]
• Number of admissions in the emergency room [Срок оценки: 12 months]
• Number of unplanned hospitalizations [Срок оценки: 12 months]
• Number of contact with general practitioner [Срок оценки: 12 months]
• benefit for clinicians: interview of clinicians on their opinion on the self-monitoring, evaluation to the impact on the consultations during the first year of treatment, assessed with satisfaction questionnaires [Срок оценки: Month 12]
• Number of AE identified by clinicians [Срок оценки: 12 months]
• Overall quality of Life assessed with standardized QoL questionnaires (FACT-G) [Срок оценки: 12 months]
• Adherence: The number of full symptoms report completions and adherence to the completion schedule [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age > 18 years
• Patients diagnosed with melanoma, or lung cancer or renal cancer
• Patients starting a treatment with a combination of immunotherapy of nivolumab + ipilimumab (NB: patients who have already received immunotherapy in the past may be included)
• Patients comfortable with the use of digital tools and computing
• Patients who agree to participate to the telemonitoring and signed consent form

Критерии исключения

• Pregnant, parturient and lactating women
• Patients under legal protection measure or deprived of their liberty
• Patients not affiliated to a social security scheme (schemes such as the AME) or beneficiaries of a similar regime (foreign person, outside the EU)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 10 центров

• Groupement hospitalier Est - Multidisciplinary oncological platform — Bron
• Hôpital Louis Pradel - Department of Pneumology — Bron
• University hospital of Grenoble Alpes - Department of dermatology — Grenoble
• University hospital of Grenoble Alpes - Department of Medical Oncology — Grenoble
• Hôpital de la Croix Rousse - Department of Pneumology — Lyon
• Hôpital Edouard Herriot - Department of urology — Lyon
• Centre Hospitalier Lyon Sud - Department of Medical Oncology — Pierre-Bénite
• Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute — Pierre-Bénite
• … и ещё 2 центра

Идентификаторы

NCT: NCT04605146 · 69HCL20_0492 · 2020-A02372-37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗