NCT Number: NCT06749925
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
Time frame: From enrollment to the end of treatment at 2 years
The primary expected outcome is overall survival, evaluated over a 2-year period.
Time frame: From enrollment to the end of treatment, limited to 2 years
Progression-free survival in months, assessed through RANO criteria (complete response, partial response, stable disease or progressing disease); Survival rates at 6 and 12 months after the initiation of vaccination; Functional status evolution, evaluated through the Karnofsky Performance Scale (KPS, ranging from 0, dead to 100, asymptomatic), WHO-ECOG scale (Eastern Cooperative Oncology Group, ranging from 0, fully active, to 5, dead), and Mini-Mental State Examination (MMSE, ranging from 0, all questions responded wrongly to 30, best performance);
Time frame: From enrollment to the end of treatment, limited to 2 years
Quality of life and general health evaluation:
FACT-Br (Functional Assessment of Cancer Therapy - Brain / 5 point Likert-type scale ranging from 0 "not at all" to 5 "very much") BCM-20 (Brain Cancer Module-20) MDASI-BT (MD Anderson Symptom Inventory for brain tumor / assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being "not present" and 10 being "as bad as you can imagine.") EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 / Likert scale ranging from 0 "not at all" to 4 or 7 "very much") EORTC QLQ-BN20 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasm 20 / 4 point Likert-type scale ranging from 0 "not at all" to 4 "very much") EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version / scale ranging from level 1: no problems to Level 5: extreme problems)
Time frame: From enrollment to the end of treatment, limited to 2 years
Levels of Th1-pattern tumor-reactive T lymphocytes in peripheral blood.
Time frame: From enrollment to the end of treatment, limited to 2 years
Adverse events classified according to the U.S. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (2010).
Contact information is provided by the study sponsor or research team.
University of Sao Paulo General Hospital
Other
Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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