NCT06749925

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2024-12-27
• Last updated: 2025-04-01