85
Participants
Start Date
May 17, 2018
Primary Completion Date
August 31, 2022
Study Completion Date
August 31, 2022
avelumab 10mg/kg with carboplatin/gemcitabine
"Dosage and schedule:~* Avelumab 10mg/kg will be administered over 60 minutes in the experimental arm as follows:~ * Intravenously every 2 weeks for two cycles.~ * During carboplatin-gemcitabine treatment, on day +15 (carboplatin will be administered on day 1; gemcitabine on days 1 and 8), for six cycles. Intravenously every 2 weeks until progressive disease o intolerance.~ * Intravenously every 2 weeks until progressive disease or intolerance.~* Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC~ * Carboplatin 5AUC day +1.~ * Gemcitabine 1000mg/m2 day +1 and +8."
carboplatin/gemcitabine alone
"•Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC~* Carboplatin 5AUC day +1.~* Gemcitabine 1000mg/m2 day +1 and +8."
Hospital Universitario 12 de Octubre, Madrid
Hospital Clínico San Carlos, Madrid
Hospital Universitario La Paz, Madrid
Hospital General Universitario Morales Meseguer, Murcia
Clínica Universidad de Navarra, Pamplona
Hospital Universitario Virgen del Rocío, Seville
Fundación Instituto Valenciano de Oncología, Valencia
Hospital General Universitario de Elche, Elche
Instituto Catalán de Oncología (ICO L'Hospitalet) - H. Durán i Reynals, L'Hospitalet de Llobregat
Fundación Althaia - Xarxa Assistencial Univ. de Manresa, Manresa
Hospital Universitario Parc Tauli, Sabadell
Hospital del Mar, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Universitario Vall d'Hebron, Barcelona
Hospital Clìnic de Barcelona, Barcelona
Merck, S.L., Spain
INDUSTRY
Pivotal S.L.
INDUSTRY
Associació per a la Recerca Oncologica, Spain
OTHER