32
Participants
Start Date
November 19, 2018
Primary Completion Date
September 29, 2020
Study Completion Date
August 16, 2022
Durvalumab
All patients will receive durvalumab (MEDI4736) (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) for up to 3 doses/cycles each, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30kg or below the patient should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W and 1mg/kg tremelimumab Q4W until the weight improves to \>30 kg, at which point the patient should start receiving the fixed dosing of durvalumab 1500mg plus tremelimumab 75 mg Q4W.
Tremelimumab
All patients will receive durvalumab (MEDI4736) (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) for up to 3 doses/cycles each, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30kg or below the patient should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W and 1mg/kg tremelimumab Q4W until the weight improves to \>30 kg, at which point the patient should start receiving the fixed dosing of durvalumab 1500mg plus tremelimumab 75 mg Q4W.
Radiotherapy
Radiotherapy at doses of 46 Gy to the minor pelvis and 64-66 Gy to the bladder.
H.U. Virgen del Rocío, Seville
Instituto Catalán de Oncología Badalona, Badalona
Hospital Universitario 12 de Octubre, Madrid
Centro Oncológico de Galicia, A Coruña
Instituto Catalán de Oncología L'Hospitalet, Barcelona
Hospital Universitario y Politécnico La Fe, Valencia
Instituto Valenciano de Oncología, Valencia
Collaborators (1)
AstraZeneca
INDUSTRY
MFAR
OTHER
Spanish Oncology Genito-Urinary Group
OTHER