A Phase I Dose Escalation Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects With or Without Chronic Viral Hepatitis
Study Classification: Pharmacokinetics/Pharmacodynamics
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of worst adverse events
All non-serious adverse events will be collected from Day 1 until 100 days after the subject's last dose of BMS-936558
Up to 100 days after the last dose of BMS-936558
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA209-040
NCT01658878
October 2012
May 2014
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |