33
Participants
Start Date
February 4, 2019
Primary Completion Date
April 14, 2022
Study Completion Date
August 31, 2023
Nivolumab
"Experimental intervention:~Immunotherapy with 4 cycles of Nivolumab: 240 mg intravenously every 2 weeks, starting one week before radiotherapy (week1, d1), last infusion on week 7, d1"
Radiation therapy of the pelvis
Neoadjuvant radiation therapy of pelvis with 45+5,4 Gy for 6 weeks: 28 x 1.8 Gy including a boost of bladder with 5.4 Gy, starting with week 2 (d1)
Radical cystectomy with standardized pelvic lymphadenectomy
Radical cystectomy with standardized bilateral pelvic lymphadenectomy: performed between week 11 - 15 (Aim: week 13)
Department of Urology, Klinikum rechts der Isar der Technischen Universität München, München
Universitätsklinikum Ulm; Klinik für Urologie, Ulm
Department of Urology, Universitätsklinikum Würzburg, Würzburg
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Technical University of Munich
OTHER