NCT05203913

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

Efficacy and Safety of the Combination of Cisplatin Plus Nab-paclitaxel and Nivolumab With Radiotherapy After Maximal Tumor Resection in Non-metastatic Muscle Invasive Bladder Cancer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase II study, eligible patients will be treated with maximal tumor resection and then started treatment within 8 weeks. Chemotherapy, Nivolumab and radiotherapy (RT) will be started on day one. Chemotherapy will be administered weekly during radiotherapy. Radiotherapy will be performed from Monday to Friday for five weeks. Nivolumab will be administered for one year (13 infusions). Patients will have the complete tumour assessment by computed tomography scan (CT-scan) and cystoscopy up to 5 years after radiotherapy.

Detailed description

The screening phase is up to six weeks before the beginning of treatment. The treatment phase is from the day one of therapy until 30 days after the last patient last cycle. During the treatment phase each patient will be treated with concomitant chemo-radiotherapy for up to five weeks. The first day of radiotherapy is considered the first day of treatment in the study and cisplatin, nab-paclitaxel and nivolumab will be administered. Cisplatin and nab paclitaxel will be administered weekly during radiotherapy for a maximum of five infusions. Nivolumab will be administered at a flat dose of 480 mg every four weeks for 13 cycles. After the end of radio-chemotherapy patients will be followed every four weeks until the end of nivolumab treatment of up to 13 cycles. Radiological assessment with whole body (abdominal/pelvic/chest) CT-scan or CT-scan of the thorax and abdominal magnetic resonance imaging (MRI). This will be performed every 16 weeks (±2 weeks) after the post radio/chemotherapy evaluation for the first two years and every six months (±2 weeks) up to 5 years. After five years patients will be followed as per local clinical practice. At the time of radiographic disease progression, patients exit from the study and will be managed as per local guidelines.

Conditions

• Muscle-Invasive Bladder Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-12-15
• Completion: 2026-06-15
• First posted: 2022-01-24
• Last updated: 2024-10-04

Locations

1 site across 1 country: Italy