Safety and Modulation of Adaptive Immunity by Iscador® Qu Viscum Album Extract in Patients With Advanced, Recurrent or Metastatic Cancers Treated With Immune Checkpoint Inhibitors
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: Immune checkpoint inhibitors plus Iscador® Qu., Immune Checkpoint Inhibitors.
- Кому может быть актуально
- Состояния в реестре: Advanced Solid Tumor. 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
- Швейцария
- 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
Safety and Modulation of Adaptive Immunity by Iscador® Qu Viscum Album Extract in Patients With Advanced, Recurrent or Metastatic Cancers Treated With Immune Checkpoint Inhibitors - a Randomized Trial
Обзор
The main objective of this study is to test if adding the mistletoe extract Iscador® Qu to regular cancer treatment with immune checkpoint inhibitors affects: * The immune system's ability to fight cancer * Safety of the treatment * How well the treatment performs against cancer * How the patient feels during treatment Researchers will compare patients treated with immune checkpoint inhibitors plus Iscador® Qu with patients treated with imune checkpoint inhibitors only.
Подробное описание
The impact of mistletoe preparations - that are claimed to have immunostimulatory properties - on cancer treatment with immune checkpoint inhibitors remains unclear. To address this knowledge gap, the current study aims to investigate the modulation of adaptive immunity through the combination of Iscador (a specific mistletoe preparation) and immune checkpoint inhibitors. Additionally, researchers will evaluate the safety profile of this combination therapy in patients with locally advanced non-operable or metastatic cancers except for skin cancers. By examining the modulation of adaptive immunity and safety of this treatment approach, researchers aim to provide valuable insights for clinicians and patients in the context of advanced cancer care.
Вмешательства
- Препарат Immune checkpoint inhibitors plus Iscador® Qu.
Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics. - Препарат Immune Checkpoint Inhibitors
Standard cancer treatment.
Первичные конечные точки
- Percentage of patients with a relative increase in T cell richness or diversity of 20% or more [Срок оценки: baseline and 12 weeks (+/- 2 weeks)]
- Percentage of patients with a relative decrease in T cell clonality of 20% or more [Срок оценки: baseline and 12 weeks (+/- 2 weeks)]
- Level of T cell richness [Срок оценки: baseline and 12 weeks (+/- 2 weeks)]
- Level of T cell diversity [Срок оценки: baseline and 12 weeks (+/- 2 weeks)]
- Level of T cell clonality [Срок оценки: baseline and 12 weeks (+/- 2 weeks)]
Вторичные конечные точки (6)
- Safety and tolerability according to the NCI CTC AE v5 [Срок оценки: up to 18 weeks]
- Rate of early immune checkpoint inhibitor-based treatment termination [Срок оценки: up to 24 months]
- Best tumor response [Срок оценки: up to 24 months]
- Progression-free survival [Срок оценки: up to 24 months]
- Overall survival [Срок оценки: up to 24 months]
- EORTC QLQ C30 [Срок оценки: up to 24 months]
Критерии участия
Критерии включения
- Locally advanced non-operable or metastatic solid tumor, except for skin cancer
- Eligible for routine (standard) treatment with immune checkpoint inhibitor (+/- chemo/targeted therapy) as per the discretion of the local investigator
- Subjects must be eligible for treatment with mistletoe preparations (controlled brain metastases, prednisolone equivalent below 10mg, no known hypersensitivity)
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2
- Males and Females at least 18 years of age; no subjects under tutelage
- No previous mistletoe treatment
Критерии исключения
- Contraindications to Iscador® Qu or immune checkpoint inhibitors, e.g. hypersensitivity, active autoimmune disorder
- Patients with skin cancer
- Participation in another study with investigational drug within 30 days prior to enrolment (participation in observational studies or diagnostic studies without a particular drug intervention are allowed)
- Enrolment of the investigator, his/her family members, employees and other dependent
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
- Лечение
Центры проведения
Швейцария · 4 центра
- Kantosspital Baden AG — Baden
- Universitätsspital Basel — Basel
- Kantonsspital Baselland — Liestal
- Tumor- und Brustzentrum Ostschweiz — Sankt Gallen
Идентификаторы
NCT: NCT06408688 · 2023-02373; th23binder