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E-Poster Display

1912TiP - NICITA: Nivolumab with chemotherapy in pleural mesothelioma after surgery

Date

17 Sep 2020

Session

E-Poster Display

Topics

Cytotoxic Therapy;  Immunotherapy

Tumour Site

Mesothelioma

Presenters

Rajiv Shah

Citation

Annals of Oncology (2020) 31 (suppl_4): S1018-S1025. 10.1016/annonc/annonc292

Authors

R. Shah1, L.V. Klotz2, M. Feißt3, M. Schneider4, M. Kriegsmann5, M. Ried6, C. Wesseler7, D.C.C. Christoph8, M. de Wit9, J. Jürgens10, H. Kopp11, T. Wehler12, M. Reck13, S. Sackmann14, C. Waller15, N. Reinmuth16, H. Bischoff17, H. Winter2, M. Eichhorn2, M. Thomas18

Author affiliations

  • 1 Dept. Of Thoracic Oncology/internal Medicine, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 2 Dept. Of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, 69126 - Heidelberg/DE
  • 3 Dept. Of Medical Biometry, Institute for Medical Biometry and Informatics, Heidelberg University, 69120 - Heidelberg/DE
  • 4 Translational Research Unit, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 5 Institute Of Pathology, University Hospital Heidelberg, 69120 - Heidelberg/DE
  • 6 Thoracic Surgery, Universitätsklinikum Regensburg, 93053 - Regensburg/DE
  • 7 Lungenheilkunde Und Thoraxzentrum, Asklepios Klinik Harburg, 21075 - Hamburg/DE
  • 8 Department Of Medical Oncology, University Hospital Essen Westdeutsches Tumorzentrum, 45147 - Essen/DE
  • 9 Department Of Hematology, Oncology And Palliative Care, Vivantes Klinikum Neukölln, 12351 - Berlin/DE
  • 10 Lungenklinik, Kliniken der Stadt Köln gGmbH, 51109 - Köln/DE
  • 11 Abt. Für Pneumologie Und Pneumologische Onkologie, Robert-Bosch-Krankenhaus, 70376 - Stuttgart/DE
  • 12 Pneumologie Und Thorakale Onkologie, Lungenklinik Hemer, 58675 - Hemer/DE
  • 13 German Center Of Lung Research, Lung Clinic Grosshansdorf, 22927 - Grosshansdorf/DE
  • 14 Department Of Pneumology, Clinic Bremen-Ost, 28325 - Bremen/DE
  • 15 Hematology, Oncology And Stem Cell Transplantation, Universitätsklinikum Freiburg Klinik für Innere Medizin Hämatologie, Onkologie und Stammzelltransplantation, 79106 - Freiburg im Breisgau/DE
  • 16 Thoracic Oncology, Asklepios-Fachklinikum, 82131 - Gauting/DE
  • 17 Lungenkrebszentrum Des Nct Heidelberg, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 18 Thoracic Oncology/internal Medicine, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE

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Abstract 1912TiP

Background

Malignant pleural mesothelioma (MPM) is a highly aggressive cancer of the pleural surface predominantly caused by prior asbestos exposure. Due to the complex nature of this disease, low patient number and paucity of prospective randomized controlled trials in this entity, there is no approved standard therapy for the treatment of early-stage MPM. Current recommended multimodal approaches include the locoregional treatment by extended pleurectomy/ decortication (eP/D), which, if feasible, can be combined with hyperthermic intrathoracic chemoperfusion (HITOC), and inductive or adjuvant chemotherapy. Taking into account the immunogenic effects of chemotherapy on the tumor microenvironment, synergistic effects are expected when combining these procedures with immune checkpoint inhibitor therapy. In addition, interactions between immune infiltrates and mesothelioma cells play a role in the advent of MPM, also implying a beneficial role for immunotherapy in this entity. Based on these considerations, we set up the NICITA investigator-initiated trial (IIT) in order to assess feasibility and efficiency of adjuvant platinum-based chemotherapy in combination with nivolumab administration in early-stage MPM patients after upfront surgery with eP/D.

Trial design

The NICITA trial is a randomized, open-label, multicenter study including patients with MPM in tumor stages I-III (UICC 8th edition) and epithelioid subtype who have previously undergone cytoreductive surgery by eP/D with or without HITOC. 92 eligible patients will be included and randomized 1:1 to receive either a combination of 4 cycles of pemetrexed/platinum-based adjuvant chemotherapy and nivolumab (480 mg q4w) followed by nivolumab maintenance therapy (12 cycles, 480 mg q4w) or 4 cycles of adjuvant chemotherapy only. Primary endpoint of this study is time-to-next-treatment. Safety endpoints are safety and tolerability. Secondary endpoints are progression-free survival, overall survival, proportion of patients with treatment beyond progression (TBP), duration of TBP and quality of life. In addition, an accompanying translational research program includes collection of tissue, blood, and stool samples for future biomarker analysis.

Clinical trial identification

NCT04177953; EudraCT: 2019-002466-13.

Editorial acknowledgement

Bristol-Myers Squibb.

Legal entity responsible for the study

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488 Frankfurt, Germany. Representative of the Sponsor: Prof. Dr. med. Salah-Eddin Al-Batran.

Funding

Bristol-Myers Squibb.

Disclosure

D.C.C. Christoph: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Bristol-Myers-Squibb; Honoraria (self), Advisory/Consultancy: Chugai; Honoraria (self), Advisory/Consultancy: MSD Merck; Honoraria (self), Advisory/Consultancy: Sharp & Dohme; Honoraria (institution), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Takeda. M. de Wit: Advisory/Consultancy: ADHOK; Honoraria (self), Travel/Accommodation/Expenses, + Registration : Roche; Honoraria (self), Travel/Accommodation/Expenses, Advisory Board: Jazz Pharamceuticals; Honoraria (self): AbbVie; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Berliner Urologische Gesellschaft; Honoraria (self), Travel/Accommodation/Expenses: Ipsen Pharma; Honoraria (self), Lecture- / or training activities: Ev. Lungenklinik Berlin; Honoraria (self), Travel/Accommodation/Expenses, Lecture- / or training activities + registration: AstraZeneca; Travel/Accommodation/Expenses, Lecture- / or training activities: DGHO; Honoraria (self), Lecture- / or training activities: Janssen; Honoraria (self), Travel/Accommodation/Expenses, Lecture- / or training activities: Takeda; Travel/Accommodation/Expenses, Lecture- / or training activities ESMO: Astellas. M. Reck: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Samsung. M. Thomas: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self), Travel/Accommodation/Expenses: Celgene; Honoraria (self), Travel/Accommodation/Expenses: Chugai; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Takeda. All other authors have declared no conflicts of interest.

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