A phase 1, Open-label, Multicenter, multidose, Dose-escalation Study of BMS-936558/MDX-1106 in Subjects with Selected Advance or Recurrent Malignancies
To assess the safety and tolerability of multiple doses of MDX-1106 in subjects with selected advanced or recurrent malignancies: Metastatic Castration-Resistant Prostate Cancer, Metastatic Melanoma, Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma,and Colorectal adenocarcinoma. It will be given in different doses. We want to find the best dose and see if we can give this study drug safely. Laboratory research suggests that MDX-1106 (BMS-936558) may help the immune system to fight cancer. In this study, the safety of MDX-1106(BMS-936558) given in multiple doses(how well people tolerate it) and its effect on your cancer and immune system will be looked at. MDX-1106 is the study drug that is being tested. It is an antibody against a molecule called PD 1. The PD-1 molecule is important because it helps control the activity of the immune system by slowing down immune responses. When your immune system is trying to fight your cancer, slowing it down may n ot be good. Blocking PD-1 may help your immune system do a better job of fighting your cancer
- recurent or refractory cancers, including non-small cell lung cancer, malignant melanoma, renal (clear) cell carcinoma, metastatic catration-resistant prostate adenocarcinoma or Colorectal adenocarcinoma. - 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
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. The infusion will be given every 14 days for a total of 4 infusions in each cycle and up to 12 cycles may be given. Participants will be required to remain in clinic for up to 1 hour after the completion of the infusion. 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.
12/09/2013 04:02 AM