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

University of Sao Paulo General Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Glioblastoma

Treatments: Biological: Dendritic Cell Vaccine; Other: Placebo; Combination Product: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06749925

58882116.7.3001.0065

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 3 patient groups, including a placebo group

DC Vaccine Arm

Experimental group

Description:

This group is receiving the dendritic cell vaccine.

Treatment:

Biological: Dendritic Cell Vaccine

DC Vaccine + Pembrolizumab Arm

Active Comparator group

Description:

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

Treatment:

Combination Product: Pembrolizumab

Placebo Control Arm

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo