NCT06749925Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- Jan 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT06749925
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 186
- From Jan 2026 to the primary completion date, Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with any concomitant neoplasm (except basal cell carcinoma).
- Participation in any experimental treatment protocols within the 6 months prior to enrollment.
Other illness
- 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.
Other
- Pregnant or breastfeeding individuals.
- Refusal or inability to provide consent, such as patients with aphasia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.