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Not yet recruiting NCT06749925

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

Phase III Interventional Glioblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dendritic Cell Vaccine, Pembrolizumab, Placebo.
Who it may be relevant to
Registry conditions: Glioblastoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological 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).
  • Combination product 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.
  • Other 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.

Primary outcome measures

  • Overall Survival [Time frame: From enrollment to the end of treatment at 2 years]
Secondary outcome measures (4)
  • Disease Progression and Survival Metrics [Time frame: From enrollment to the end of treatment, limited to 2 years]
  • Quality of life and general health assessment [Time frame: From enrollment to the end of treatment, limited to 2 years]
  • Immunological Response [Time frame: From enrollment to the end of treatment, limited to 2 years]
  • Safety Profile [Time frame: From enrollment to the end of treatment, limited to 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06749925 · 58882116.7.3001.0065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗