Durvalumab Plus Tremelimumab With Concurrent Radiotherapy for Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 19, 2018

Primary Completion Date

September 29, 2020

Study Completion Date

August 16, 2022

Conditions
Invasive Bladder Cancer
Interventions
DRUG

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.

DRUG

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.

RADIATION

Radiotherapy

Radiotherapy at doses of 46 Gy to the minor pelvis and 64-66 Gy to the bladder.

Trial Locations (7)

41013

H.U. Virgen del Rocío, Seville

08024

Instituto Catalán de Oncología Badalona, Badalona

Hospital Universitario 12 de Octubre, Madrid

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

MFAR

OTHER

lead

Spanish Oncology Genito-Urinary Group

OTHER