Clinical trial NCT06749925: Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma
Official title: Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Glioblastoma
Keywords: glioblastoma
dendritic cell
vaccine
clinical trial
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Survival
timeFrame: From enrollment to the end of treatment at 2 years
Secondary outcomes:
measure: Disease Progression and Survival Metrics
timeFrame: From enrollment to the end of treatment, limited to 2 years
measure: Quality of life and general health assessment
timeFrame: From enrollment to the end of treatment, limited to 2 years
measure: Immunological Response
timeFrame: From enrollment to the end of treatment, limited to 2 years
measure: Safety Profile
timeFrame: From enrollment to the end of treatment, limited to 2 years
Other outcomes:
Locations:
Study officials:
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