RecruitingPhase 1NCT05304208

dENdritic Cell Therapy Combined With SURgEry in Mesothelioma

Phase I, Open-Label Study With Dendritic Cell Therapy (MesoPher) In Combination With Ex-tended-Pleurectomy/Decortication After Chemotherapy in Subjects With Resectable Mesothelioma

Sponsor

Erasmus Medical Center

Enrollment

16 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

Mesotheliomas Pleural

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (DECISIVE) tests a combination of dendritic cell therapy (a type of immune treatment made from the patient's own cells) and surgery for mesothelioma — a cancer of the lining of the lung, usually linked to asbestos exposure. The goal is to see if the immune therapy improves outcomes after surgery. **You may be eligible if...** - You have been diagnosed with epithelioid malignant pleural mesothelioma (a specific cell type of this cancer) - Your cancer is at a surgically removable stage (stage I–IIIA) - You are eligible for platinum-based chemotherapy followed by surgery - You are at least 18 years old and in good enough health for surgery **You may NOT be eligible if...** - You have a non-epithelioid type of mesothelioma - Your cancer is too advanced for surgery - You have significant other health problems that prevent surgery or chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMesopher

autologous monocyte-derived DCs loaded with PheraLys (tumor cell lysate)

Locations(1)

Erasmus MC

Rotterdam, South Holland, Netherlands

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NCT05304208

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