Abstract 1641TiP
Background
Recently, a dual immunotherapy was approved in unresectable Malignant pleural mesothelioma (MPM). There is, however, no approved standard therapy for the treatment of early-stage MPM. A multimodal therapy, consisting of extended pleurectomy/decortication (eP/D) together with inductive or adjuvant chemotherapy is generally recommended. Considering the immunogenic effects of chemotherapy on the tumor microenvironment, synergistic effects are expected when such a treatment is combined with immune checkpoint inhibitor, as already shown by recent clinical data in patients with advanced MPM. The NICITA trial combines the above-mentioned considerations and assesses feasibility and efficacy of an innovative therapy consisting of adjuvant platinum-based chemotherapy with nivolumab in patients with MPM who have undergone surgical cytoreduction with eP/D.
Trial design
The NICITA trial (NCT04177953) is a randomized, open-label, phase II clinical trial that is conducted in 14 centers in Germany. Patients, diagnosed with MPM in stages I-III (UICC 8th edition) and epithelioid subtype, who have already undergone cytoreductive surgery by eP/D. Patients with hyperthermic intrathoracic chemoperfusion (HITOC) can be included. Patients are 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 takes place according to previous HITOC treatment (yes vs. no), performance status (ECOG 0,1 vs. 2), and achievement of macroscopic complete resection (yes vs. no). The primary endpoint is time-to-next-treatment. Secondary endpoints include progression-free survival, overall survival, measures of treatment-beyond-progression and quality of life, as well as the assessment of safety and tolerability. Furthermore, a comprehensive collection of biomarker samples, including tumor tissue, blood, and stool samples, for an accompanying translational research program is implemented. As of 30th April 2022, 63 of 92 planned patients have been enrolled into the NICITA trial.
Clinical trial identification
NCT04177953; EudraCT 2019-002466-13; AIO Study Number AIO-TRK/YMO-0419.
Editorial acknowledgement
Legal entity responsible for the study
Institute of Clinical Cancer Research (IKF) - Frankfurt, Germany.
Funding
unrestricted grant from Bristol Myers Squibb GmbH & Co.KGaA (BMS).
Disclosure
R. Shah: Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche; Non-Financial Interests, Principal Investigator, The NICITA trial is sponsored by the Institute of Clinical Cancer Research (IKF), and funded by an unrestricted grant from Bristol Myers Squibb GmbH & Co. KGaA (BMS): Thoraxklinik, University Hospital Heidelberg; Non-Financial Interests, Member: ESMO, German Cancer Society, Center for Lung Research - Germany, Thoracic Oncology Working Group (German Cancer Society); Non-Financial Interests, Other, Board member: Pneumo-Oncology Working Group (German Cancer Society).