A Study of the Biologic Effects of Nivolumab (BMS-936558) in Patients with Inoperable or Metastatic Melanoma

Protocol
12-231
Full Title
An Exploratory Study of the Biologic Effects of Nivolumab and Ipilumab Monotherapy and Nivolumab in Combination with Ipilimumab Treatment in Subjects with Advanced Melanaoma (Unresectable or Metastatic)
Phase
I
Purpose

The purpose of this study is to determine if an investigational drug called nivolumab (BMS-936558) is safe and well tolerated in patients with melanoma that has spread (metastasized) or cannot be surgically removed. Nivolumab 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.

Nivolumab is given intravenously (by vein).

Eligibility

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

  • Patients must have advanced (inoperable or metastatic) melanoma.
  • Patients may have had no more than three prior regimens of therapy.
  • At least 6 weeks must have passed since completion of prior therapy and entry into the study.
  • Prior therapy with an anti-PD-1 drug is not permitted.
  • 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jedd Wolchok at 646-888-2395.

Disease(s)
Melanoma
Locations
Related Diseases