TRIO Bladder: A Study of Durvalumab Plus Tremelimumab Followed by Concurrent Durvalumab Plus Bladder Radiation in Muscle-Invasive Bladder Cancer

Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Tremelimumab will be administered intravenously at a dose of 75 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long.

"Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long.~Eligible subjects may go on to receive a combination of durvalumab and bladder radiation during cycles 3 and 4. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 3 day 1 and cycle 4 day 1.~At the completion of radiation, eligible subjects may continue to receive durvalumab for a maximum of one year from the date of their initial dose. Durvalumab will be administered intravenously at a dose of 1500 mg on the first day of each cycle."

During the durvalumab cycles 3 and 4, eligible subjects will receive 6.5 weeks of radiation to the bladder. Radiation will be administered at a dose of 64 Gy in daily 2 Gy fractions.

Subjects will receive intravesicular therapy, if clinically indicated during cycles 5 and beyond of durvalumab administration. Intravesicular therapy will consist of BCG, gemcitabine, mitomycin or a similar drug, depending on institutional standards and treating provider's discretion.