Treatment for Patients with Bladder Cancer that has Spread into the Muscle Tissue
Lay Title: A new study to treat your bladder cancer that has spread into the muscle tissue
Technical Title: Randomized Phase II Study of Neoadjuvant Nivolumab with and without Urelumab in Patients with Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the Bladder
Disease Type: Muscle-invasive urothelial carcinoma of the bladder. This study is for patients who are planning to undergo cystectomy (surgical removal of some or all of the bladder) and are not eligible to be treated with standard cisplatin-based chemotherapy.
The purpose of this research study is to study the effects, safety, and tolerability of the study drugs nivolumab and urelumab when given to people who have advanced bladder cancer that has spread into the muscle issue. Patients on this study will be randomized to be treated with a combination of nivolumab and urelumab, or with nivolumab alone. Patients will receive treatment for approximately 2 months before their planned cystectomy (removal of bladder).
Nivolumab is FDA-approved to treat other types of cancer, but not bladder cancer. Urelumab is investigational, meaning it is not approved for marketing by the FDA. Both nivolumab and urelumab are administered intravenously (IV, or through a vein).
Research Procedures (not a complete list):
Patients who are randomized to receive both nivolumab and urelumab will receive nivolumab every 2 weeks, and urelumab once every 4 weeks. Patients who are randomized to receive nivolumab alone will receive nivolumab every 2 weeks. Patients in both groups will be treated for a maximum of 2 months. There will be at least 3 visits during the first month and at least 2 visits during the second month to receive treatment and complete physical exams and blood/urine tests.
On the day of planned cystectomy, the research team will collect blood and urine samples for research.
After cystectomy, patients will be asked to return to clinic after 1 and 3 months for a physical exam and blood and urine samples.
Eligibility Criteria (not a complete list):
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