OncoMatch/Clinical Trials/NCT05304208
dENdritic Cell Therapy Combined With SURgEry in Mesothelioma
Is NCT05304208 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Mesopher for mesotheliomas pleural.
Treatment: Mesopher — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage I, II, IIIA (UICC TNM classification (8th edition))
Excluded: Stage IV
Resectable disease defined by stage cT1-3, N0-1, M0 (I to IIIA) according to UICC TNM classification (8th edition). ... absence of M1, N2 involvement is required. ... 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).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
eligible for 2 to 4 cycles of platinum-based chemotherapy
Cannot have received: any prior treatment for mesothelioma
Prior treatment of any kind for mesothelioma, especially prophylactic track irradiation after diagnostic procedures.
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, and Hb ≥9.0 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
Kidney function
creatinine ≤ 1.5 × ULN or glomerular filtration rate ≥ 50 mL/min
Liver function
ALT, AST, bilirubin ≤ 1.5 × ULN
adequate organ function and adequate bone marrow reserve at screening: creatinine ≤ 1.5 × ULN or glomerular filtration rate ≥ 50 mL/min; ALT, AST, bilirubin ≤ 1.5 × ULN; Absolute neutrophil count ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, and Hb ≥9.0 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
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