Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

Официальное название

Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation

Обзор

The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer

Подробное описание

This study will be a prospective, multicentric, single-arm cohort. Patients will receive Nivolumab-Cabozantinib association per standard. All patients will benefit of geriatric evaluation (G-CODE) at inclusion, and a multimodal and reinforced follow-up, including medical oncologist, geriatrician nurse of doctor, phone calls, and optional pharmacological follow-up for Cabozantinib.

Вмешательства

• Препарат Nivolumab
  Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.
• Препарат Cabozantinib
  Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.

Первичные конечные точки

• Starting dose of Cabozantinib [Срок оценки: 24 weeks after treatment start]
• Dose interruption of Cabozantinib [Срок оценки: 24 weeks after treatment start]
• Dose modifications of Cabozantinib [Срок оценки: 24 weeks after treatment start]

Вторичные конечные точки (8)

• Overall response rate based on radiological evaluation [Срок оценки: 12 months after treatment start]
• Overall-survival [Срок оценки: 12 months after treatment start]
• Progression free survival [Срок оценки: 12 months after treatment start]
• Duration of response [Срок оценки: 12 months after treatment start]
• Frequency of adverse events according to CTCAE V5 [Срок оценки: 12 months after treatment start]
• Frequency of adverse events according to PRO-CTCAE [Срок оценки: 12 months after treatment start]
• Quality of life - Patient-related outcomes - FACT-G [Срок оценки: At baseline, and every 3 months after treatment start, up to 12 months after treatment start]
• Quality of life - Patient-related outcomes - FACIT TS-G [Срок оценки: Every 3 months after treatment start, up to 12 months after treatment start]

Критерии участия

Критерии включения

• Patients ≥ 70 years-old
• Confirmed advanced or metastatic renal-cell carcinoma
• Patients not previously treated in metastatic setting
• Performance Status 0 to 2
• Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
• Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
• Patients must be affiliated to a social security system or beneficiary of the same

Критерии исключения

• Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)
• Performance Status > 2
• Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria)
• Any severe cardiovascular or thrombo-embolic event in the last three months
• Any situation for which exclusive palliative care intervention is recommended
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

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 · 7 центров

• Institut de Cancérologie de l'Ouest - Angers — Angers
• Centre Georges François Leclerc — Dijon
• Centre Léon Bérard — Lyon
• Hôpital Tenon — Paris
• Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud — Toulouse
• CHU Tours - Hôpital Bretonneau — Tours
• Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT06934057 · 2024-516650-22-00 · 2024/3873

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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