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Идёт набор NCT07161310

Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

Без фазы С лечением Solid Cancer Non-Small Cell Lung Cancer Melanoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Urolithin A, Placebo, Bio specimens.
Кому может быть актуально
Состояния в реестре: Solid Cancer, Non-Small Cell Lung Cancer, Melanoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

Обзор

The aim of this clinical study is to learn more about the effects of urolithin A (MitoPure®) on the immune system of cancer patients receiving immune checkpoint inhibitor-based therapies. Any effects will be compared with patients who take a placebo instead of urolithin A (MitoPure®).

Вмешательства

  • Пищевая добавка Urolithin A
    Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.
  • Пищевая добавка Placebo
    Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.
  • Другое Bio specimens
    Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.

Первичные конечные точки

  • Change in the composition of circulating lymphocytes [Срок оценки: From enrollment to the end of urolithin A intake at 8-9 weeks]
Вторичные конечные точки (2)
  • Changes in the plasma cytokine profile [Срок оценки: From enrollment to the end of urolithin A intake at 8-9 weeks]
  • Transcriptional changes in immune cells [Срок оценки: From enrollment to the end of urolithin A intake at 8-9 weeks]

Критерии участия

Критерии включения

  • Newly diagnosed solid cancer without previous systemic anticancer treatment
  • Planned single agent or double agent immune checkpoint inhibitor therapy as first-line standard-of-care treatment either with or without chemotherapy. Of note, patients receiving neoadjuvant therapy are eligible
  • Age ≥ 18 years
  • Life-expectancy ≥ 3 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits and scheduled follow-up visits and examinations
  • Female patients of childbearing potential (WOCBP) are only eligible if using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:
  • Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
  • Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.
  • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation

Критерии исключения

  • Patients who currently receive or have received cytostatic chemotherapy, glucocorticoids, or immune modulatory agents (including low-dose methotrexate, TNF alpha inhibitors, calcineurin inhibitors, interleukin inhibitors, etc.) during the last 3 months are not eligible. Of note, topical glucocorticoid treatments and hormone replacement therapy is acceptable
  • Patients who currently take or plan to take mitochondrial supplements like coenzyme q10, NAD+ boosters (e.g. nicotineamide riboside, nicotineamine mononucleotide), or L-carnitine
  • Patients who have received radiotherapy to the mediastinum or to other areas with anticipated strong irradiation of a large blood vessel by the judgement of the investigator are not eligible
  • Patients with known HIV infection are not eligible. Testing is not mandatory
  • Patients with a history of solid organ or hematopoietic cell transplantation6. Any medical condition that in the opinion of the investigators would compromise the study outcome or the safety of the patient

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
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Германия · 1 центр
  • Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie — Frankfurt

Идентификаторы

NCT: NCT07161310 · Mito Cancer

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗