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

NCT ID: NCT06749925

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DC Vaccine Arm

This group is receiving the dendritic cell vaccine.

Group Type: EXPERIMENTAL

Dendritic Cell Vaccine

Intervention Type: 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).

DC Vaccine + Pembrolizumab Arm

This group is receiving the dendritic cell vaccine combined with pembrolizumab.

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: 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 Control Arm

This group is receiving a placebo and serves as the control.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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).

Intervention Type: BIOLOGICAL

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jose Alexandre Marzagão Barbuto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

José Alexandre Marzagão Barbuto

Role: CONTACT

jbarbuto@icb.usp.br

+55 11 3091-7375

Other Identifiers

58882116.7.3001.0065

Identifier Type: -

Identifier Source: org_study_id