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

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT06749925
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dendritic Cell Vaccine — BIOLOGICAL
    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).
  • Pembrolizumab — COMBINATION_PRODUCT
    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.
  • Placebo — OTHER
    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.

Study Details

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.

Key Dates

First listed
Dec 27, 2024
Start date
Jan 31, 2026
Status verified
Mar 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DC Vaccine Arm
    This group is receiving the dendritic cell vaccine.
  • Active Comparator: DC Vaccine + Pembrolizumab Arm
    This group is receiving the dendritic cell vaccine combined with pembrolizumab.
  • Placebo Comparator: Placebo Control Arm
    This group is receiving a placebo and serves as the control.

Primary Outcome Measure

Overall Survival [ Time Frame: From enrollment to the end of treatment at 2 years ]

Central Contacts

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