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dENdritic Cell Therapy Combined With SURgEry in Mesothelioma

Study acronym: ENSURE
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2025 → Dec 31, 2027
See other at-risk trials from Erasmus Medical Center

Record History

  1. Primary completion pushed from Dec 31, 2025 to Dec 31, 2027 Completion pushed from Dec 31, 2026 to Dec 31, 2028 · Eligibility criteria expanded, about 35 words · Secondary endpoints: details revised at 2 of 2 entries Show 3 more changesShow less
    • Completion pushed from Dec 31, 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025 Completion date: Dec 31, 2025 to Dec 31, 2026v4 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2026
  3. Re-verified, no change to tracked fieldsv3
  4. Study arms: 0 to 1v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05304208
Lead Sponsor Erasmus Medical Center
Conditions Mesotheliomas Pleural
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov