Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05203913
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Roberto Iacovelli, MD, PhD
Phone +390630157373
Status Recruiting
Phase Phase 2
Start date May 1, 2023
Completion date June 15, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05097404 - Clinical Utility of VI-RADS in Diagnosis of MIBC
Recruiting NCT05483868 - A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer Phase 1
Not yet recruiting NCT04966130 - Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
Active, not recruiting NCT04610671 - Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC Phase 1
Recruiting NCT05776758 - Role of NAC in cT0 Muscle-invasive Bladder Cancer After Maximal TURBt Phase 3
Recruiting NCT06341400 - RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients Phase 1/Phase 2
Recruiting NCT05790850 - Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial) N/A
Recruiting NCT05295992 - Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach N/A
Recruiting NCT06215976 - The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer Phase 4
Recruiting NCT05028660 - AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study
Not yet recruiting NCT04909775 - Chemotherapy Combined With Tislelizumab as Bladder Sparing Option for Patients With Muscle Invasive Bladder Cancer Phase 2
Recruiting NCT04876313 - An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo) Phase 2
Not yet recruiting NCT04686149 - a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients
Active, not recruiting NCT05630131 - ctDNA in Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy
Recruiting NCT06170177 - Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
Terminated NCT05221827 - Clinical Performance Evaluation of the C2i-Test
Recruiting NCT06257017 - Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial Phase 2
Recruiting NCT05767528 - Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection
Completed NCT04598724 - Addressing Barriers to Palliative Care Use in Bladder Cancer
Recruiting NCT05975307 - Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation Phase 2