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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT05203913
Phase
PHASE2
Status
Recruiting
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Conditions

  • Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    The recommended dose for nivolumab is 480 mg administered as 30 minutes IV infusions every 28 days for 13 infusions.
  • Nab paclitaxel — DRUG
    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 — DRUG
    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 — RADIATION
    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.

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Sep 2024
Primary completion
Dec 15, 2025
Completion
Jun 15, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    This arm consists in treatment with cisplatin + nab-paclitaxel + nivolumab during radiotherapy on bladder followed by nivolumab alone after the end of radiotherapy

Primary Outcome Measure

Disease-free survival [ Time Frame: From the start of therapy up to 5 years. ]

Central Contacts

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