''A Phase 1, Open-label, Multicenter, Dose-escalation, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects with Selected Advanced or Recurrent Solid Tumors''.
The purpose of this research study is to test an experimental (investigational) drug which is a fully human monoclonal antibody targeting the immune system and how it works against tumors. This is an investigational drug which has not been approved by the U.S. Food and drug Administration (FDA). It will be given at different doses. We want to find the best dose and determine if we can give safely. Laboratory research suggests the MDX-1105(BMS-936559) may help the immune system to fight off cancer. MDX-1105 is the study drug that is being tested. It is an antibody against a molecule called PD1-L1. The PD1-L1 molecule is important because it helps control the activity of the immune system by slowing down immune responses. Blocking PD1-L1 molecule may help your immune system do a better job of fighting your cancer
- recurrent or refractory cancers, including non-small cell lung cancer, epithelial ovarian cancer, malignant melanoma , renal cell carcinoma, epithlial ovarian cancer, gastric cancer, pancreatic cancer, or breast cancer. - 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 not have had prior therapy with anti-PD-1, anti-CTLA-4 antibody or any other T-cell targeted therapy.
The study drug will be given to you as an intravenous (IV) infusion. This means it will be given as an injection into a vein. It will last for about an hour. It may cause some pain. When you are finished getting MDX-1105 you will stay in the medical facility for at up to 2 hours for observation. During this time, the study team will check your vital signs. They will also observe you for side effects of the study drug. More blood samples will be taken to measure the level of the study drug in your blood. In total, about 5 tablespoons of blood will be taken during this first day. Samples will be sent to the central outside lab and some duplicate blood testing may also be tested at Hopkins. There will be 5 dose levels. 0.1, 0.3, 1, 3 and 10 mg/kg/dose. In each dose level, a person will recieve 3 doses per cycle and up to 16 cycles of the drug. 1 year of Follow-Up and 1 year of Re-initiation should you progress during Follow-Up Phase. The maximum duration of the study drug treatment is 4 years.
05/23/2013 04:06 AM