Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma

Официальное название

SPRINT - Short Moderate Physical Regime INtervention Directly Before ImmunoTherapy for Melanoma

Обзор

The aim of this research project is to determine whether a short bout of physical exercise immediately before the start of immunotherapy (Nivolumab and Ipilimumab) is feasible and has a positive effect on the effectiveness of immunotherapy. It is known that short-term physical exercise leads to marked changes in the innate and adaptive immune system. These changes-specifically an increase in natural killer (NK) cells and cytotoxic T cells-are associated with a better response to immunotherapy. The patient population selected for this study consists of patients with advanced-stage melanoma who are receiving Nivolumab and Ipilimumab. First, we aim to assess whether such an intervention is feasible in a large proportion of patients, as many patients experience disease-related and treatment-related side effects. Secondary objectives are to demonstrate that the exercise intervention positively influences the immune system and that this, in turn, leads to an improved response to therapy, thereby positively affecting patient survival, improving quality of life, and reducing treatment-related side effects.

Вмешательства

• Поведенческое 30 Minutes Cycle Ergometer
  Moderate physical activity for 30 minutes on a cycle ergometer

Первичные конечные точки

• Feasibility rate [Срок оценки: 9 weeks]

Вторичные конечные точки (5)

• PFS [Срок оценки: Time from randomization to progression or death from any cause, up to 30 months.]
• Increase of NK cells and T cells or T cell subsets auch as CD103/CD39-positive CD8 T cells in the peripheral blood after cycling [Срок оценки: Difference calculated between blood draw directly before and directly after sport intervention.]
• OS [Срок оценки: Time from randomization to progression or death from any cause, up to 30 months.]
• Increase of cytokines and chemokines, i.e. IL-15 after cycling [Срок оценки: Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.]
• Side effects [Срок оценки: Occurrence of side effects during active therapy with nivolumab and ipilimumab; the rate per patient is calculated from randomization to the end of the trial. Up to 30 months.]

Критерии участия

Критерии включения

• Histologically confirmed metastatic malignant melanoma with an indication for immunotherapy (Nivolumab and Ipilimumab).
• The participant provides written informed consent for the study.
• The participant is at least 18 years of age on the day the informed consent is signed.
• No prior systemic anticancer therapy for metastatic disease (e.g., cytotoxic or targeted agents).
• ECOG (Eastern Cooperative Oncology Group) performance status score of ≤ 2.
• No physical impairment that would preclude participation in physical exercise.

Критерии исключения

• Major surgery within 2 weeks prior to the start of the study intervention, or participants who have not fully recovered from the effects of a previous surgery.
• Participants with a diagnosed immunodeficiency, or those receiving chronic systemic corticosteroid therapy (at a dose greater than 10 mg prednisone equivalent per day), or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study medication.
• Participants with an active infection requiring systemic therapy.
• Participants with a known history of infection with human immunodeficiency virus (HIV) or hepatitis.

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

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• University Medical Center Hamburg-Eppendorf — Hamburg

Идентификаторы

NCT: NCT07564570 · Version 1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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