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Adjuvant dendritic-cell immunotherapy plus temozolomide following surgery and chemoradiation in patients with newly diagnosed glioblastoma
EU CTIS ID: 2024-515291-13-00
What this study is testing
To determine the overall survival (OS) and progression-free survival (PFS) of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 mRNA-loaded dendritic-cell vaccination is added to adjuvant temozolomide maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Newly diagnosed, histologically verified glioblastoma (WHO grade IV)
- Life expectancy ≥ 3 months as estimated by the Investigator
- Aged ≥ 18 years
- Total or subtotal resection: (A) Total resection = macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (≤ 72h) brain MRI (B) Subtotal resection = macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement ≤ 2 cm³ on post-operative (≤ 72h) brain MRI
- Signed informed consent
- Willing and able to comply with the protocol as judged by the Investigator
You likely can't join if
- History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise
- Prior radiation or chemotherapy
- Any pre-existing contraindication for temozolomide treatment
- Any pre-existing contraindication for contrast-enhanced brain MRI
- Pregnant or breast-feeding
- Documented immune deficiency or systemic immune-suppressive treatment
See the full eligibility criteria
- Newly diagnosed, histologically verified glioblastoma (WHO grade IV)
- Life expectancy ≥ 3 months as estimated by the Investigator
- Aged ≥ 18 years
- Total or subtotal resection: (A) Total resection = macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (≤ 72h) brain MRI (B) Subtotal resection = macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement ≤ 2 cm³ on post-operative (≤ 72h) brain MRI
- Signed informed consent
- Willing and able to comply with the protocol as judged by the Investigator
- Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection
- Fit to undergo: leukapheresis, chemoradiation, chemotherapy and immunotherapy
- No corticosteroid treatment ≤ 1 week before apheresis
- WHO performance status ≤ 2
- History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise
- Prior radiation or chemotherapy
- Any pre-existing contraindication for temozolomide treatment
- Any pre-existing contraindication for contrast-enhanced brain MRI
- Pregnant or breast-feeding
- Documented immune deficiency or systemic immune-suppressive treatment
- Known positive viral serology for HIV, HBV, HCV, or syphilis
- Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.