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

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Erasmus MC




Patients with locally advanced or metastatic NSCLC (stage IIIB to stage IV)



Dendritic Cell therapy (MesoPher) In Combination With Extended- Pleurectomy/Decortication

Key inclusion criteria

Inclusion criteria:

  • Patients with a histologically confirmed diagnosis of epithelioid MPM who are eligible for 2 to 4 cycles of platinum-based chemotherapy. Patients who progressed after chemotherapy
    will not be discontinued from the trial if they are still eligible for eP/D and none of the exclusion criteria is present (e.g. local progression with only focal chest invasion)
  • Resectable disease defined by stage cT1-3, N0-1, M0 (I to IIIA) according to UICC TNM classification (8th edition). FDG-PET-CT scan with fusion images showing absence of M1, N2 involvement is required. Focal chest wall lesions are acceptable
  • Tumor tissue available after completing chemotherapy and before starting treatment with DCT. Tumor tissue can be obtained by either a CT-guided needle biopsy or a VATS surgical biopsy.
  • Fit to receive platinum-based chemotherapy (as per standard of care of the treating physician/Institution) and undergo a P/D with optional removal of hemidiaphragm and pericardium. The responsible surgeon and chest physician should judge the required fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary, cardiac) examinations

Key exclusion criteria

Exclusion criteria:

  • Clinical or radiological invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.) and widespread chest wall invasion (stage T4). Involvement of N2 nodes
  • Stage IV (metastatic disease).

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