Actively Recruiting
dENdritic Cell Therapy Combined With SURgEry in Mesothelioma
Led by Erasmus Medical Center · Updated on 2025-04-25
16
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The ENSURE trial is an open label, single center, phase 1, feasibility study. Sixteen adult patients diagnosed with resectable epithelioid malignant pleural mesothelioma (MPM) will be enrolled following first-line chemotherapy. Before standard-of-care chemotherapy, a leukapheresis will be performed and monocytes will be used for differentiation to dendritic cells (DCs) using specific cytokines. Allogeneic tumor lysate (Pheralys) loaded autologous DCs (MesoPher) will be re-injected 3 weeks after completing chemotherapy, 2 times every other week. Four weeks after the first injection with dendritic cell therapy (DCT), patients will undergo extrapleural pleurectomy/decortication (eP/D) surgery and receive three bi-weekly injections with DCT (starting 4 weeks after surgery). In total, five DC vaccinations will be administered. A tumor biopsy will be collected before starting neo-adjuvant DCT.
CONDITIONS
Official Title
dENdritic Cell Therapy Combined With SURgEry in Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed epithelioid malignant pleural mesothelioma eligible for 2 to 4 cycles of platinum-based chemotherapy
- Patients aged 18 years or older able to give written informed consent
- Resectable disease defined by specific staging (cT1-3, N0-1, M0) with required imaging showing no distant spread
- Tumor tissue available after chemotherapy and before starting dendritic cell therapy
- Fit to receive chemotherapy and undergo extrapleural pleurectomy/decortication surgery
- Eastern Cooperative Oncology Group performance status 0-1
- Ability to return to the study center for follow-up and vaccinations
- Positive delayed-type hypersensitivity skin test against tetanus toxoid
- Adequate organ and bone marrow function at screening
- Women of childbearing potential must have negative pregnancy tests and agree to effective contraception during and for 12 months after the study
- Men must agree to use effective contraception during and for 12 months after the study
- Written informed consent according to ICH-GCP guidelines
You will not qualify if you...
- Invasion of mediastinal structures or widespread chest wall invasion (stage T4) and metastatic disease (stage IV)
- Any histology other than epithelioid malignant pleural mesothelioma
- No available tumor tissue after chemotherapy
- Medical, psychological, or psychiatric conditions interfering with consent or study procedures
- Use of more than 10 mg prednisolone or immunosuppressive agents within 6 weeks before study drug administration
- Major surgery or significant injury within 28 days before randomization
- Previous malignancies unless disease-free for at least 3 years, except some skin or bladder cancers
- Prior treatment for mesothelioma other than standard chemotherapy
- Significant pleural effusion not manageable by standard methods
- Active serious infections including HIV, hepatitis B or C, or syphilis
- History of autoimmune disease except certain cases after medical review
- Organ transplant recipients
- Serious chronic or acute illnesses posing high risk for surgery or therapy
- Pregnant, nursing, or unwilling to use contraception as required
- Inadequate vein access for leukapheresis
- Recent investigational treatment within 28 days
- Lack of compliance assurance or follow-up availability
- Known allergy to shellfish (may contain KLH)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
J
Joachim Aerts, Prof
CONTACT
L
Luca Cantini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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