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A Phase II Trial of Nivolumab With Chemotherapy Followed by Maintenance Nivolumab in Patients With Pleural Mesothelioma After Surgery: The NICITA Study Protocol

  • Rajiv Shah
    Correspondence
    Address for correspondence: Rajiv Shah, MD, Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany
    Affiliations
    Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany

    Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany
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  • Laura V. Klotz
    Affiliations
    Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany

    Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany
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  • Inn Chung
    Affiliations
    Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany

    Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany
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  • Manuel Feißt
    Affiliations
    Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany
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  • Marc A. Schneider
    Affiliations
    Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany

    Translational Research Unit, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany
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  • Johanna Riedel
    Affiliations
    Institute of Clinical Cancer Research IKF at Northwest Hospital GmbH, Frankfurt am Main, Germany
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  • Helge Bischoff
    Affiliations
    Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany

    Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany
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  • Martin E. Eichhorn
    Affiliations
    Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany

    Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany
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  • Michael Thomas
    Affiliations
    Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany

    Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany
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Published:October 14, 2020DOI:https://doi.org/10.1016/j.cllc.2020.10.005

      Abstract

      Background

      In selected patients with early-stage malignant pleural mesothelioma (MPM), a multimodal therapy that includes surgical cytoreduction, chemotherapy, and/or radiotherapy is recommended. Several clinical trials have demonstrated the beneficial effects of immune checkpoint inhibitors in pretreated MPM patients with advanced disease. Recent clinical data have suggested that the combination of chemotherapy and checkpoint inhibition might improve efficacy.

      Trial Design

      The NICITA (nivolumab with chemotherapy in pleural mesothelioma after surgery) trial is a prospective, 1:1 randomized, open-label, multicenter phase II clinical trial (ClinicalTrials.gov identifier, NCT04177953). Ninety-two patients with MPM epithelioid subtype, who had undergone extended pleurectomy and decortication with or without hyperthermic intrathoracic chemoperfusion, will be included to receive adjuvant treatment. All patients will receive ≤ 4 cycles of platinum-based chemotherapy with pemetrexed (arms A and B). Patients in arm B will additionally receive nivolumab, together with the adjuvant chemotherapy, and subsequently for ≤ 12 cycles as maintenance therapy. The primary endpoint of this study is the time-to-next-treatment. The secondary endpoints include progression-free survival, overall survival, proportion of patients with treatment beyond progression, duration of treatment beyond progression in this population, and quality of life.

      Conclusion

      This prospective trial will contribute data to assess the efficacy of standard chemotherapy combined with nivolumab in the context of multimodal management of early-stage MPM. The study is currently enrolling patients.

      Keywords

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