A Phase III Study of Nivolumab Immunotherapy versus Placebo to Treat High-Risk Urothelial Cancers after Surgery

Full Title

CA209274: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma

Purpose

Nivolumab is an immunotherapy drug used to treat several types of cancer. It boosts the body's immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body's white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body's ability to detect and destroy cancer cells. It is given intravenously (by vein).

In this study, researchers want to see if nivolumab is effective for treating urothelial (bladder, ureter, or renal pelvis) cancers that have been surgically removed and have a high risk of coming back or spreading. Patients will be randomly assigned to receive nivolumab or a placebo (inactive drug).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have cancer of the bladder, ureter, or renal pelvis that has been surgically removed and has a high risk of coming back.
  • Patients may not have had chemotherapy or radiation therapy after their cancer surgery. Therapy before surgery is permitted and must have been completed within 4 weeks of entering the study.
  • 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. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-422-4333.

Protocol

16-1484

Phase

III

Investigator

Locations