Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

December 15, 2025

Study Completion Date

June 15, 2026

Conditions
Muscle-Invasive Bladder Carcinoma
Interventions
DRUG

Nivolumab

The recommended dose for nivolumab is 480 mg administered as 30 minutes IV infusions every 28 days for 13 infusions.

DRUG

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.

DRUG

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.

RADIATION

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.

Trial Locations (1)

00168

RECRUITING

Roberto iacovelli, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER