J12102:An Exploratory Study of the Biologic Effects of Nivolumab(BMS-936558/CA209-038 (Anti-PD1 Monoclonal Antibody) Treatment in Subjects with Advanced Melanoma (Unresectable or Metastatic)
BMS-936558 (Anti-PD-1) is an experimental drug not yet approved by the Food and Drug Administration (FDA) and is being developed to treat advanced melanoma. The study will enroll the participants with recurrent or treatment-refractory malignant melanoma. BMS-936558 (Anti-PD-1) is a human monoclonal antibody. An antibody is a type of protein that helps protect the body against foreign matter, such as bacteria and viruses. This type of therapy based on the same idea of the body's natural defense system which protects against various diseases. It may use and enhance the body's own natural ability to defend itself against malignant tumors.
Malignant melanoma with available tumors for biopsy. Prior treatment completed at least 4 weeks before study drug is given - good physical condition - good blood counts - no active autoimmune disease - no active infection - no steroid use -may have had Yervoy as a previous treatment.
The study drugs will be given to you as an intravenous (IV) infusion. This means it will be given as an injection into a vein. Each one will last for about an hour. It may cause some pain. The BMS936558 infusion will be given every 14 days for a total of 4 infusions in each cycle and up to 12 cycles may be given. The expected maximum duration of study drug treatment for a participant is approximately 3 years. The expected maximum duration for a participant is 4 years.
12/18/2013 04:02 AM