Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1). The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
281
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
The Angeles Clinic & Research Institute
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105
Time frame: Weekly
Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105
Time frame: Bi-weekly
Preliminary efficacy in solid tumors on the basis of objective responses
Time frame: Day 42
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oncology Consultants, Pa
Houston, Texas, United States
The University Of Texas
Houston, Texas, United States
...and 1 more locations