Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 17, 2018

Primary Completion Date

August 31, 2022

Study Completion Date

August 31, 2022

Conditions
Metastatic Urothelial Cancer
Interventions
COMBINATION_PRODUCT

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."

COMBINATION_PRODUCT

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."

Trial Locations (15)

28026

Hospital Universitario 12 de Octubre, Madrid

28040

Hospital Clínico San Carlos, Madrid

28046

Hospital Universitario La Paz, Madrid

30008

Hospital General Universitario Morales Meseguer, Murcia

31008

Clínica Universidad de Navarra, Pamplona

41013

Hospital Universitario Virgen del Rocío, Seville

46009

Fundación Instituto Valenciano de Oncología, Valencia

03203

Hospital General Universitario de Elche, Elche

08907

Instituto Catalán de Oncología (ICO L'Hospitalet) - H. Durán i Reynals, L'Hospitalet de Llobregat

08243

Fundación Althaia - Xarxa Assistencial Univ. de Manresa, Manresa

08208

Hospital Universitario Parc Tauli, Sabadell

08003

Hospital del Mar, Barcelona

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clìnic de Barcelona, Barcelona

All Listed Sponsors
collaborator

Merck, S.L., Spain

INDUSTRY

collaborator

Pivotal S.L.

INDUSTRY

lead

Associació per a la Recerca Oncologica, Spain

OTHER

NCT03390595 - Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma | Biotech Hunter | Biotech Hunter