Expanded Access to MK-3475 for Patients with Metastatic Melanoma with Few to No Treatment Options

Protocol
14-093
Full Title
Expanded Access of MK-3475 in Metastatic Melanoma Patients with Limited to No Treatment Options
Phase
II
Purpose

Through this program, the investigational drug MK-3475 will be provided to patients with metastatic melanoma who have tried other treatments and who have few or no other treatment options. In prior studies of patients with advanced melanoma, some patients who received MK-3475 experienced tumor shrinkage and cancer control for a long period of time.

MK-3475 is a protein called an antibody which binds to PD-1, a protein on T cells (a type of white blood cell). It is hoped that when MK-3475 binds to PD-1, it will “turn on” the T cells and cause the immune system to detect and destroy cancer cells. MK-3475 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 inoperable (stage III) or metastatic (stage IV) melanoma that has continued to grow despite prior therapy that included ipilimumab and, when indicated, an inhibitor of BRAF/MEK (such as vemurafenib, trametinib, or dabrafenib).
  • Patients may not have previously received MK-3475.
  • 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 12 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Michael Postow at 646-888-4589.

Disease(s)
Melanoma
Locations
Related Diseases