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Clinical Trials

Topic   Invasive Urothelial Carcinoma
Title   A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma
Summary   This is a phase 3 trial of adjuvant Nivolumab versus placebo in adult male or female patients who have undergone radical resection of Invasive Urothelial Carcinoma and are at high risk for recurrence. Nivolumab is an intravenous immunotherapy used to treat several types of cancer. Immunotherapy is treatment that uses specific parts of the immune system to fight cancer. Nivolumab enhances the body’s immune system. Cancers have to ability to disrupt the body’s normal immune functions, thereby escaping the body’s immune system. Some cancers interfere with a receptor found on the white blood cell called PD-1. This ability gives the cancer an advantage against the body’s immune system. PD-1 normally is responsible for shutting down the immune system. Nivolumab inactivates PD-1. This helps the body’s white blood cells to detect and attack the cancer. In this research study, patients will be randomly selected to get Nivolumab or a placebo. The research team is looking to see if Nivolumab will work in treating invasive urothelial cancer.
Description   Urothelial cancers affect the urinary system. The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in patients who have undergone radical surgery for invasive urothelial cancer.
IRB Number   20152609
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following:
  • This study is for patients age 18 and older.
  • Must have had invasive urothelial cancer
  • Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 90 days
  • Must have disease free status as determined by imaging within 4 weeks of dosing
  • Tumor tissue must be provided for biomarker analysis
Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. For example, patients must be well enough that they would be able to carry out office work or light housework.
Status   Open
Start Date   02/06/2016
Principal Name   Mary O’Keeffe, MD
Contact Name   Jennifer Brown, RN
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-3115
Alternate Phone   516-663-8391