Durvalumab (MEDI4736) and TREmelimumab in NEOadjuvant Bladder Cancer Patients (DUTRENEO)

PHASE2CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

October 25, 2018

Primary Completion Date

April 30, 2021

Study Completion Date

April 12, 2023

Conditions
Bladder Cancer
Interventions
DRUG

Durvalumab

Durvalumab 1500 mg every 4 weeks x 3 cycles

DRUG

Tremelimumab

Tremelimumab 75 mg every 4 weeks x 3 cycles

DRUG

Cisplatin-based neoadjuvant chemotherapy

"Regimen 1: 21-day treatment cycle x 3 cycles.~* Gemcitabine 1,000-1,200 mg/m2 intravenously on days 1 and 8 every 21 days.~* Cisplatin 70 mg/m2 intravenously on day 1 every 21 days. Regimen 2: ddMVAC 14-day treatment cycle x 4 doses.~* Methotrexate 30mg/m2 intravenously on day 1~* Vinblastine 3mg/m2 intravenously on day 2~* Doxorubicin 30mg/m2 intravenously on day 2~* Cisplatin 70mg/m2 intravenously on day 2 Granulocyte colony-stimulating factor (G-CSF) for 7 consecutive days (days 4 through 10).~Regimen 3: 21-day treatment cycle x 3 cycle~* Gemcitabine 1,000 mg/m2 intravenously on day 1 and 8~* Paclitaxel 80 mg/m2 intravenously on day 1 and 8~* Cisplatin 70mg/m2 intravenously on day 1"

Trial Locations (11)

Unknown

ICO Badalona, Badalona

Hospital Clinic, Barcelona

Hospital de la Santa Creu i Sant Pau, Barcelona

ICO L'Hospitalet, L'Hospitalet de Llobregat

Hospital 12 de Octubre, Madrid

Hospital Clinico San Carlos, Madrid

Hospital Ramon y Cajal, Madrid

Hospital Universitario La Paz, Madrid

MD Anderson Cancer Center, Madrid

Hospital Marqués de Valdecilla, Santander

Instituto Valenciano de Oncología, Valencia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Apices Soluciones S.L.

INDUSTRY

lead

Fundacion CRIS de Investigación para Vencer el Cáncer

OTHER