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

March 31, 2025 updated by: Jose Alexandre Marzagão Barbuto, University of Sao Paulo General Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: José Alexandre Marzagão Barbuto
  • Phone Number: +55 11 3091-7375
  • Email: jbarbuto@icb.usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DC Vaccine Arm
This group is receiving the dendritic cell vaccine.
Biological: Dendritic Cell Vaccine
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).
Active Comparator: DC Vaccine + Pembrolizumab Arm
This group is receiving the dendritic cell vaccine combined with pembrolizumab.
Combination product: Pembrolizumab
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.
Placebo Comparator: Placebo Control Arm
This group is receiving a placebo and serves as the control.
Other: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Progression and Survival Metrics
Time Frame: From enrollment to the end of treatment, limited to 2 years
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);
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

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)
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
Levels of Th1-pattern tumor-reactive T lymphocytes in peripheral blood.
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
Adverse events classified according to the U.S. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (2010).
From enrollment to the end of treatment, limited to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58882116.7.3001.0065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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