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Brief Title: Platinum-doublet Chemotherapy and Nivolumab for the Treatment of Subjects With Neuroendocrine Neoplasms (NENs) of the Gastroenteropancreatic (GEP) Tract or of Unknown (UK) Origin.
Official Title: 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.
Study ID: NCT03980925
Brief Summary: This is a prospective, multi-centre, open label, non-randomized phase II study evaluating the efficacy and safety of nivolumab plus platinum-based chemotherapy in patients with advanced G3 NENs of the GEP tract or of UK origin.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Català d'Oncologia Badalona, Badalona, Barcelona, Spain
Institut Català d'Oncologia l'Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Vall d'Hebron University Hospital, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
MD Anderson Cancer Madrid, Madrid, , Spain
Hospital Clínico Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Name: Rocío García-Carbonero, MD, PhD
Affiliation: Hospital Universitario 12 de Octubre
Role: STUDY_CHAIR
Name: Maria del Carmen Riesco-Martínez, MD, PhD
Affiliation: Hospital Universitario 12 de Octubre
Role: STUDY_CHAIR