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

NCT06749925 | Not Yet Recruiting Phase 3

• 1 other identifier: 58882116.7.3001.0065
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

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

Keywords

glioblastoma; dendritic cell; vaccine; clinical trial

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The primary expected outcome is overall survival, evaluated over a 2-year period.

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (4)

• Disease Progression and Survival Metrics

  From enrollment to the end of treatment, limited to 2 years

• Quality of life and general health assessment

  From enrollment to the end of treatment, limited to 2 years

• Immunological Response

  From enrollment to the end of treatment, limited to 2 years

• Safety Profile

  From enrollment to the end of treatment, limited to 2 years

Study Arms (3)

DC Vaccine Arm

EXPERIMENTAL

This group is receiving the dendritic cell vaccine.

Biological: Dendritic Cell Vaccine

DC Vaccine + Pembrolizumab Arm

ACTIVE COMPARATOR

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

Combination Product: Pembrolizumab

Placebo Control Arm

PLACEBO COMPARATOR

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

Other: Placebo

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).

DC Vaccine Arm

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.

DC Vaccine + Pembrolizumab Arm

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.

Placebo Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

José Alexandre Marzagão Barbuto

CONTACT

+55 11 3091-7375; jbarbuto@icb.usp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 1, 2025

Record last verified: 2025-03