A phase II study of Platinum-doublet chemotherapy in combination with nivolumab as first-line treatment, in subjects with unresectable, locally advanced or metastatic G3 Neuroendocrine Neoplasms (NENs) of the gastroenteropancreatic (GEP) tract or of unknown (UK) origin. - NICE-NEC

Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)0 个研究点目标入组 38 人开始时间: 2019年6月11日最近更新: 2019年12月10日

试验速览

暂无简介。

•- Histologically confirmed G3 NENs originated in the gastroenteropancreatic tract (WHO 2015/2019 classification). Patients with a G3 NEN of unknown primary will also be eligible for this trial.
•- Ki-67 >20% or mitotic rate > 20 per 10 HPF.
•- Metastatic or locally advanced unresectable disease not amenable to treatment with curative intent.
•- No prior systemic treatment for advanced disease nor as adjuvant therapy permitted.
•- Availability of fresh or archive formalin-fixed, paraffin-embedded tumor tissue for biomarker assessment.
•- Patients must have clinically and/or radiographically documented measurable disease.
•- Adequate organ function as defined by the following criteria absolute neutrophil count (ANC) =1500 cells/mm3; platelets =100,000 cells/mm3; hemoglobin =9.0 g/dL; AST and ALT =2.5 x upper limit of normal (ULN); in patients with liver metastases AST and ALT =5.0 x ULN; total bilirubin =1.5 x ULN;
•serum creatinine =1.5 x ULN or calculated creatinine clearance =60 mL/min.
•- ECOG performance status of 0-2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•- The following endocrine tumor types may not be included: paraganglioma, adrenal, thyroid parathyroid or pituitary endocrine tumors. Large or small cell lung neuroendocrine carcinoma of the lung will also be excluded.
•- Prior therapy with any immune checkpoint inhibitor.
•- Prior organ transplantation, including allogeneic stem-cell transplantation.
•- Systemic chronic steroid therapy (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents or use of any investigational drug within 28 days before the start of trial treatment.
•- Known history of positive testing for Human Immunodeficiency Virus (HIV) infection, known history of positive tests for Hepatitis B virus surface antigen (HBVsAg) or Hepatitis C ribonucleic acid (HCV RNA) indicating acute or chronic infection or other significant acute or chronic infections requiring medication at study entry.

发起方

Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)