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Studieoverzicht

Study name: ENSURE

Histology Other
Tumor stage Stage I - III
Host / recruiting sites Erasmus MC
Enrollment Recruiting
Therapy line First line (1L)
Design
  • This is an open label, single center, phase 1 study
Intervention
  • Before standard-of-care chemotherapy, a leukapheresis will be performed and monocytes will be used for differentiation to 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 DCT, patients will undergo eP/D surgery and receive three bi-weekly injections with DCT (starting 4 weeks after surgery). In total, five DC vaccinations will be administered.
Key outcome parameters
  • Primary end-point: To determine the feasibility of DCT with Mesopher performed before and after eP/D in patients with resectable epithelioid MPM who received first line chemotherapy.
Key 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.
  • ECOG performance status 0–1 (Appendix
Key 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).
  • Any different histology from the epithelioid MPM (as per assessed at time of diagnosis).
  • Unavailability of tumor tissue after completing chemotherapy and before starting treatment with DCT.
  • Prior treatment of any kind for mesothelioma, especially prophylactic track irradiation after diagnostic procedures.
  • Clinically significant pleural effusion that cannot be managed with thoracentesis or pleurodesis (according to institutional practice). If pleurodesis is considered, it should be done before randomization.
  • Inadequate peripheral vein access to perform leukapheresis
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