32
Participants
Start Date
May 1, 2023
Primary Completion Date
December 15, 2025
Study Completion Date
June 15, 2026
Nivolumab
The recommended dose for nivolumab is 480 mg administered as 30 minutes IV infusions every 28 days for 13 infusions.
Nab paclitaxel
The recommended dose for nab-paclitaxel is 60 mg per square meter administered as 30 minutes IV infusions every 7 days (weekly), during the radiotherapy period.
Cisplatin
The recommended dose for cisplatin is 20 mg per square meter administered as 60 minutes IV infusions every 7 days (weekly), during the radiotherapy period.
Radiotherapy
Radiotherapy will be delivered over approximately 5 weeks.The total radiotherapy dose will be: 60 Gray in 25 fractions over 5 weeks on original bladder tumour, 50 Gray in 25 fractions over 5 weeks on whole bladder and pelvic nodes if included, administered as concomitant boost. Radiation therapy will be delivered once daily (Monday-Friday) continuously without a planned break for tumour response assessment during treatment.
RECRUITING
Roberto iacovelli, Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER