A multicenter, randomized, phase II/III study of dendritic cells loaded with allogeneic tumor cell lysate (MesoPher) in subjects with mesothelioma as maintenance therapy after chemotherapy: DENdritic cell Immunotherapy for Mesothelioma (DENIM) trial

Translational Lung Cancer Research
Robert A BelderbosJoachim G J V Aerts

Abstract

Malignant pleural mesothelioma (MPM) is an aggressive, treatment resistant neoplasm. The current treatment, consisting of antifolate and platinum-based chemotherapy, improves the median overall survival with only 3 months. Adjuvant bevacizumab generates an additional 2 months survival benefit. Checkpoint inhibitors (CI) have shown promising clinical effects in only a minority of patients. A possible reason is that MPM patients have low numbers of tumor-infiltrating CD8+ T-cells. Dendritic cell (DC) therapy can induce an immune response and activate tumor-specific CD8+ T-cells. Allogeneic mesothelioma tumor-lysate loaded DC therapy has proven effective in mice and safe and feasible in humans. We have designed a randomized, phase II/III, multicenter, open-label trial to examine the efficacy of DC therapy in humans with histologically proven MPM. In this open-label, multicenter, randomized phase II/III trial patients will be randomized to receive either DC therapy plus best supportive care (BSC) or BSC alone according to the discretion of the local investigator after first line chemotherapy treatment. The primary end point will be overall survival. The secondary endpoints will be safety and tolerability, progression-free survival,...Continue Reading

Citations

Jun 26, 2020·Frontiers in Oncology·Robert A BelderbosJoachim G J V Aerts
Apr 10, 2020·Frontiers in Oncology·Christophe BlanquartDidier Jean
Apr 1, 2020·Frontiers in Oncology·Luca CantiniJoachim G J V Aerts
Feb 11, 2020·Frontiers in Oncology·Fabio NicoliniMassimiliano Mazza
Jan 1, 2021·Expert Opinion on Drug Discovery·Kenneth P SeastedtChuong D Hoang
Nov 14, 2020·Current Opinion in Oncology·Katharina SinnM Alireza Hoda
May 5, 2021·Expert Opinion on Emerging Drugs·Alexander P DavisNick Pavlakis
Jul 3, 2021·Cancers·Anne-Laure DésageMarios E Froudarakis
Jul 3, 2021·Cancers·Rita TerenzianiMara Bonelli
Aug 17, 2021·Cancer Treatment Reviews·Wanyuan Cui, Sanjay Popat
Aug 24, 2021·Current Treatment Options in Oncology·Elizabeth DudnikLiran Holtzman
Jul 7, 2021·British Journal of Cancer·Joanna ObaczStefan J Marciniak

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