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

Phase 3

Not yet recruiting

• Conditions: Glioblastoma
• Interventions: Biological: Dendritic Cell Vaccine; Combination Product: Pembrolizumab; Other: Placebo

• Registration Number: NCT06749925
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-11-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-01
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 186

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DC Vaccine Arm	Dendritic Cell Vaccine	This group is receiving the dendritic cell vaccine.
DC Vaccine + Pembrolizumab Arm	Pembrolizumab	This group is receiving the dendritic cell vaccine combined with pembrolizumab.
Placebo Control Arm	Placebo	This group is receiving a placebo and serves as the control.

Primary Outcome Measures

Name	Time	Method
Overall Survival	From enrollment to the end of treatment at 2 years	The primary expected outcome is overall survival, evaluated over a 2-year period.

Secondary Outcome Measures

Name	Time	Method
Disease Progression and Survival Metrics	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);
Quality of life and general health assessment	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)
Immunological Response	From enrollment to the end of treatment, limited to 2 years	Levels of Th1-pattern tumor-reactive T lymphocytes in peripheral blood.
Safety Profile	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).