Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma

Официальное название

Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma

Обзор

This Phase III, multicenter, placebo-controlled clinical trial with sequential randomization is designed to evaluate the efficacy and safety of an experimental vaccine composed of hybrid dendritic cells (DCs) for the treatment of glioblastoma. Conducted at the Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP) and the Institute of Biomedical Sciences of the University of São Paulo (ICB/USP), the study is led by Professor José Alexandre Marzagão Barbuto. A multidisciplinary team of researchers specializing in neurosurgery, pathology, hematology, and other fields will contribute to a comprehensive approach. The trial aims to determine whether the hybrid DC vaccine can increase overall survival in adult patients with glioblastoma who have completed standard treatment, including surgery, chemotherapy, and radiotherapy. Secondary objectives include evaluating progression-free survival, quality of life, immune response, and the safety of the intervention. The study will enroll 186 patients, who will be randomized into three groups: (1) a control group receiving placebo, (2) a group receiving the DC vaccine, and (3) a group receiving the DC vaccine combined with pembrolizumab.

Вмешательства

• Биопрепарат Dendritic Cell Vaccine
  This intervention distinguishes itself from others by utilizing allogeneic dendritic cells derived from healthy donors fused with autologous tumor cells from patients, which is a novel approach compared to the commonly used autologous DC-based vaccines (DCVax).
• Комбинированный продукт Pembrolizumab
  Recent findings have shown that the anti-PD1 monoclonal antibody, a checkpoint inhibitor, can sustainably enhance the anti-tumor immune response. In this study, all patients in the intervention group (vaccine) who reach the fifth dose will be randomized to receive either pembrolizumab or a placebo as an addition to the experimental treatment regimen.
• Другое Placebo
  In this study, all patients in the intervention group (vaccine) who reach the fifth dose will be randomized to receive either pembrolizumab or a placebo as an addition to the experimental treatment regimen.

Первичные конечные точки

• Overall Survival [Срок оценки: From enrollment to the end of treatment at 2 years]

Вторичные конечные точки (4)

• Disease Progression and Survival Metrics [Срок оценки: From enrollment to the end of treatment, limited to 2 years]
• Quality of life and general health assessment [Срок оценки: From enrollment to the end of treatment, limited to 2 years]
• Immunological Response [Срок оценки: From enrollment to the end of treatment, limited to 2 years]
• Safety Profile [Срок оценки: From enrollment to the end of treatment, limited to 2 years]

Критерии участия

Критерии включения

• Adult patients with a histological diagnosis of glioblastoma and confirmed IDH status.
• Currently undergoing standard-of-care treatment, which includes surgery, chemotherapy, and radiotherapy.
• Availability of pre-treatment magnetic resonance imaging (MRI).
• Ability to attend clinical follow-ups every 2 months.
• Functional performance score > 50 at the time of study enrollment.
• Tumor cells capable of expansion in culture.

Критерии исключения

• Patients with any concomitant neoplasm (except basal cell carcinoma).
• Pregnant or breastfeeding individuals.
• Patients with significant medical or surgical conditions as determined by the study team, psychiatric disorders, or those requiring medications or treatments that could interfere with study procedures or the evaluation of the vaccine's safety and efficacy.
• Patients who are HIV-positive, immunosuppressed, and/or have undergone organ transplantation.
• Refusal or inability to provide consent, such as patients with aphasia.
• Participation in any experimental treatment protocols within the 6 months prior to enrollment.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06749925 · 58882116.7.3001.0065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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