GlioblastomaPhase 3NCT06749925
Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma
A Phase 3 study testing Dendritic Cell Vaccine and Pembrolizumab in people with Glioblastoma, run by University of Sao Paulo General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Dendritic Cell Vaccine and Pembrolizumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma
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
- Being tested
- Dendritic Cell Vaccine, Pembrolizumab, Placebo
- Keywords
- glioblastoma, dendritic cell, vaccine, clinical trial
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell VaccineBiological
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).
PembrolizumabCombination 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DC Vaccine Arm | Experimental | This group is receiving the dendritic cell vaccine. Receives: Biological: Dendritic Cell Vaccine |
| DC Vaccine + Pembrolizumab Arm | Active comparator | This group is receiving the dendritic cell vaccine combined with pembrolizumab. Receives: Combination Product: Pembrolizumab |
| Placebo Control Arm | Placebo comparator | This group is receiving a placebo and serves as the control. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The primary expected outcome is overall survival, evaluated over a 2-year period.
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (4)
Disease Progression and Survival Metrics
Progression-free survival in months, assessed through RANO criteria (complete response, partial response, stable disease or progressing disease); Survival rates at 6 and 12 months after the initiation of vaccination; Functional status evolution, evaluated through the Karnofsky Performance Scale (KPS, ranging from 0, dead to 100, asymptomatic), WHO-ECOG scale (Eastern Cooperative Oncology Group, ranging from 0, fully active, to 5, dead), and Mini-Mental State Examination (MMSE, ranging from 0, all questions responded wrongly to 30, best performance);
Measured: From enrollment to the end of treatment, limited to 2 years
Quality of life and general health assessment
Quality of life and general health evaluation:
FACT-Br (Functional Assessment of Cancer Therapy - Brain / 5 point Likert-type scale ranging from 0 "not at all" to 5 "very much") BCM-20 (Brain Cancer Module-20) MDASI-BT (MD Anderson Symptom Inventory for brain tumor / assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being "not present" and 10 being "as bad as you can imagine.") EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 / Likert scale ranging from 0 "not at all" to 4 or 7 "very much") EORTC QLQ-BN20 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasm 20 / 4 point Likert-type scale ranging from 0 "not at all" to 4 "very much") EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version / scale ranging from level 1: no problems to Level 5: extreme problems)
Measured: From enrollment to the end of treatment, limited to 2 years
Immunological Response
Levels of Th1-pattern tumor-reactive T lymphocytes in peripheral blood.
Measured: From enrollment to the end of treatment, limited to 2 years
Safety Profile
Adverse events classified according to the U.S. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (2010).
Measured: From enrollment to the end of treatment, limited to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Alexandre Marzagão Barbuto, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749925
- Sponsor's protocol ID
- 58882116.7.3001.0065
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma
- ClinicalTrials.gov ID
- NCT06749925
- Acronym / sponsor ID
- 58882116.7.3001.0065
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, dendritic cell, vaccine, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DC Vaccine Arm | Experimental | Biological: Dendritic Cell VaccineThis group is receiving the dendritic cell vaccine. |
| DC Vaccine + Pembrolizumab Arm | Active comparator | Combination Product: PembrolizumabThis group is receiving the dendritic cell vaccine combined with pembrolizumab. |
| Placebo Control Arm | Placebo comparator | Other: PlaceboThis group is receiving a placebo and serves as the control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dendritic Cell VaccineThis 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). | Biological | DC Vaccine Arm |
| PembrolizumabRecent 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. | Combination product | DC Vaccine + Pembrolizumab Arm |
| PlaceboIn 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. | Other | Placebo Control Arm |
Primary outcome
Overall Survival
Time frame: From enrollment to the end of treatment at 2 years
The primary expected outcome is overall survival, evaluated over a 2-year period.
4 secondary outcomes
Disease Progression and Survival Metrics
Time frame: From enrollment to the end of treatment, limited to 2 years
Quality of life and general health assessment
Time frame: From enrollment to the end of treatment, limited to 2 years
Immunological Response
Time frame: From enrollment to the end of treatment, limited to 2 years
Safety Profile
Time frame: From enrollment to the end of treatment, limited to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dendritic Cell Vaccine and Pembrolizumab in people with Glioblastoma, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Alexandre Marzagão Barbuto (+55 11 3091-7375, jbarbuto@icb.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From enrollment to the end of treatment at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.