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1188TiP NICE-NEC, a phase II study of platinum-doublet chemotherapy in combination with nivolumab as first-line treatment in subjects with unresectable, locally advanced or metastatic grade 3 neuroendocrine neoplasms (NENs) of the gastroenteropancreatic tract or of unknown origin. GETNE-T1913

2020; Elsevier BV; Volume: 31; Linguagem: Inglês

10.1016/j.annonc.2020.08.2092

1569-8041

María Carmen Riesco Martínez, Jaume Capdevila, Vicente Alonso, Àlex Teulé, Enrique Grande, Paula Jiménez‐Fonseca, Marta Benavent, Teresa Alonso Gordoa, Ana Custodio, C. Hierro Carbó, Carlos López, Isabel García, Rocio García‐Carbonero,

Neuroblastoma Research and Treatments

Grade 3 (G3) NENs comprise a subgroup of neuroendocrine neoplasms with a high proliferative index and aggressive behaviour. Median overall survival (OS) of patients (pts) with advanced disease is up to 12 months with the best available platinum-based chemotherapy. Therefore, there is a great need for more effective therapeutic options in this setting. G3 NENs are highly mutated tumors with increased PD-L1 expression, which is strongly associated with response to immunotherapy. The aim of this study is to assess safety and efficacy of adding immune check-point inhibitors to standard chemotherapy in pts with advanced chemo-naïve G3 NENs. NICE-NEC is a non-randomized open-label phase II trial recruiting pts with metastatic or unresectable G3 NENs of gastroenteroenpathic (GEP) or unknown (UK) origin across 12 Spanish centers from the Spanish Taskforce of Neuroendocrine Tumors (GETNE). Study treatment comprises an initial induction phase with 6 cycles of Nivolumab 360 mg / Carboplatin AUC 5 / Etoposide 100 mg/m2/d administered intravenously (IV) on days 1/1/1-3, respectively, every 21; followed by maintenance treatment with Nivolumab 480 mg IV every 4 weeks, up to 2 years or disease progression, whatever occurred first. Key inclusion criteria are histologically confirmed non-resectable or stage IV G3 (Ki-67>20%) NENs, GEP or UK primary, measurable disease, no prior systemic treatment, adequate organ function and ECOG ≤2. Primary objective is to determine one-year OS rate. Secondary objectives: objective response rate, progression free survival (PFS), and duration of response according to RECIST 1.1, safety and exploratory assessment of predictive and prognostic biomarkers. The sample size was calculated with 80% power to test H0 (1-year OS rate of 0.5), requiring 38 pts, yielding a two-sided type I error rate of 5% when the true one-year OS rate is 0.72. NICE-NEC accrual started on October 2019 and is currently actively recruiting patients. 16 pts have been enrolled to date, the last patient of the last visit is expected for 2Q 2022. EudraCT: 2019-001546-18. Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE). Bristol-Myers Squibb.