Radio-Immunotherapy Before Cystectomy in Locally Advanced Urothelial Carcinoma of the Bladder

PHASE2UnknownINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

February 4, 2019

Primary Completion Date

April 14, 2022

Study Completion Date

August 31, 2023

Conditions
Urinary Bladder Cancer
Interventions
DRUG

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

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)

PROCEDURE

Radical cystectomy with standardized pelvic lymphadenectomy

Radical cystectomy with standardized bilateral pelvic lymphadenectomy: performed between week 11 - 15 (Aim: week 13)

Trial Locations (3)

Unknown

Department of Urology, Klinikum rechts der Isar der Technischen Universität München, München

Universitätsklinikum Ulm; Klinik für Urologie, Ulm

Department of Urology, Universitätsklinikum Würzburg, Würzburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Technical University of Munich

OTHER