V-183 Nivolumab with chemotherapy in pleural mesothelioma after surgery – the NICITA trial

Hintergrund

Malignant pleural mesothelioma (MPM) is a highly lethal cancer of the pleura associated with exposure to asbestos. Currently, there is no approved standard treatment of early-stage MPM. If possible, a multimodal treatment by cytoreductive surgery with or without hyperthermic intrathoracic chemoperfusion (HITOC) in combination with inductive or additive chemotherapy is performed. Considering the immunogenic effects of chemotherapy on the tumor microenvironment, synergistic effects might be potentiated in combination with immune checkpoint inhibitor therapy. Moreover, interactions between immune infiltrates and mesothelioma cells have been described to have a beneficial impact for immunotherapy in MPM.

Material und Methode

The NICITA trial is a randomized, open-label, phase II clinical trial conducted in 12 centers across Germany. Eligible patients have been diagnosed with MPM in tumor stages I-III (UICC 8^th edition) and epithelioid subtype, and must have undergone lung-sparing cytoreductive surgery with or without HITOC. Patients will be 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. Stratification will take place according to previous HITOC treatment, ECOG status, and achievement of macroscopic complete resection.

Ergebnis

In March 2021, 29 out of 92 patients have been included in the NICITA trial (ClinicalTrials.gov identifier: NCT04177953). The primary endpoint is time-to-next-treatment and secondary endpoints include progression-free survival, overall survival, quality of life, and the assessment of safety and tolerability. Comprehensive analysis of biomarker samples (tumor tissue, blood, and stool samples) are also implemented in this translational research project.

Schlussfolgerung

The NICITA investigator-initiated trial (IIT) combines the assessment of feasibility and efficiency of an innovative and multimodal treatment approach consisting of lung-sparing cytoreductive surgery and adjuvant platinum-based chemotherapy in combination with the immune checkpoint inhibitor nivolumab in early-stage MPM.

Publication History

Article published online:
06 September 2021