RecruitingPhase 2NCT05203913

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.


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

32 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy (cisplatin and nab-paclitaxel), immunotherapy (nivolumab), and radiation therapy after surgery for patients with muscle-invasive bladder cancer who want to keep their bladder rather than have it removed entirely. **You may be eligible if...** - You are 18 or older - You have been diagnosed with muscle-invasive bladder cancer (stage T2–T3, no lymph node involvement or spread to other organs) - You had surgery to remove as much of the bladder tumor as possible (TURBT) - You do not have cancer spread to lymph nodes or elsewhere on PET scan **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You have small cell bladder cancer histology - You have had prior radiation to the pelvis - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

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

DRUGNab 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.

DRUGCisplatin

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.

RADIATIONRadiotherapy

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.


Locations(1)

Roberto iacovelli

Roma, Italy

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NCT05203913


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