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

Our plain-English summary of A Phase II Trial of Nivolumab With Chemotherapy Followed by Maintenance Nivolumab in Patients With Pleural Mesothelioma After Surgery: The NICITA Study Protocol, by R. Shah, L.V. Klotz, I. Chung, et al (Clinical Lung Cancer, 2021).

The study

• Authors: R. Shah, L.V. Klotz, I. Chung, M. Feißt, M.A. Schneider, J. Riedel, H. Bischoff, M.E. Eichhorn, M. Thomas
• Journal: Clinical Lung Cancer
• Published: 2021;22(2):142-146
• Cited by: 13 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

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.

Copyright © 2020 Elsevier Inc. All rights reserved.

In plain English

This article is a study protocol. It describes a planned clinical trial, called NICITA, that was enrolling patients, and it reports no results. The trial was designed as a randomized, open-label phase II trial at twelve sites in Germany. It planned to include 92 patients with epithelioid malignant pleural mesothelioma, stage I to III. All had already had surgery to remove as much tumor as possible (extended pleurectomy and decortication), with or without heated chemotherapy given into the chest during the operation (HITOC). Every patient was to receive up to four cycles of platinum-based chemotherapy with pemetrexed. Patients in one of the two arms (arm B) were also to receive the immunotherapy drug nivolumab together with the chemotherapy, and then nivolumab alone for up to 12 cycles as maintenance. The authors said the trial would contribute data on how well standard chemotherapy combined with nivolumab works within multi-step treatment of early-stage disease. The article does not examine asbestos exposure.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Study protocol for a prospective, randomized (1:1), open-label, multicenter phase II clinical trial; no results are reported
• Who was studied: 92 patients planned, with malignant pleural mesothelioma (MPM), stage I-III, epithelioid subtype, who had undergone maximal cytoreductive surgery by extended pleurectomy and decortication (eP/D) with or without hyperthermic intrathoracic chemoperfusion (HITOC), at twelve sites in Germany
• Exposure: Treatment studied (not asbestos exposure): up to four cycles of platinum-based chemotherapy with pemetrexed in both arms; arm B additionally receives nivolumab with the chemotherapy and then for up to 12 cycles as maintenance therapy
• The authors' conclusion: The authors stated that the trial will contribute data to assess the efficacy of standard chemotherapy combined with nivolumab in the multimodal management of early-stage MPM, and that it was enrolling patients.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Nivolumab (Opdivo), Chemotherapy, Pleural Mesothelioma, Multimodal Therapy, Cytoreductive Surgery, Clinical Trial, checkpoint inhibitors, Epithelioid.

Related studies

• A Phase II Trial of First-Line Combination Chemotherapy With Cisplatin, Pemetrexed, and Nivolumab for Unresectable Malignant Pleural Mesothelioma: A Study Protocol — N. Fujimoto, K. Aoe, et al. (2018)
• CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial — D.A. Fennell, E. Kirkpatrick, et al. (2018)
• Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial — A. Scherpereel, J. Mazieres, et al. (2019)
• A phase II trial of pleurectomy/decortication followed by intrapleural and systemic chemotherapy for malignant pleural mesothelioma — V. Rusch, L. Saltz, et al. (1994)
• LUME-Meso: Design and Rationale of the Phase III Part of a Placebo-Controlled Study of Nintedanib and Pemetrexed/Cisplatin Followed by Maintenance Nintedanib in Patients With Unresectable Malignant Pleural Mesothelioma — G.V. Scagliotti, R. Gaafar, et al. (2017)
• Importance of excision repair cross-complementation group 1 and ribonucleotide reductase M1 as prognostic biomarkers in malignant pleural mesothelioma treated with platinum-based induction chemotherapy followed by surgery — L. Frischknecht, M. Meerang, et al. (2015)

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