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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Article info
Publication history
Published online: October 14, 2020
Accepted:
October 8,
2020
Received in revised form:
October 5,
2020
Received:
July 27,
2020
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
