The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles, California, United States
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests
The incidence of adverse events will be tabulated and reviewed for potential significance and clinical Importance.
Time frame: Every 3 weeks from Baseline (Day 1) for up to 2 years
Dose-limiting toxicity and maximum tolerated dose of Urelumab (BMS-663513) as determined by the incidence of dose-limiting toxicities
Time frame: Every 3 weeks from Baseline (Day 1) for up to 9 weeks of therapy
Maximum observed serum concentrations (Cmax) of Urelumab (BMS-663513)
Time frame: Cycle 1 Day 1
Minimum observed serum concentrations (Cmin) of Urelumab (BMS-663513)
Time frame: Cycle 2 Day 1, Cycle 3 Day 1, every 12 weeks thereafter up to 2 years
Time of maximum observed serum concentration (Tmax) of Urelumab (BMS-663513)
Time frame: Cycle 1 Day 1
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of Urelumab (BMS-663513)
Time frame: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years
Plasma half-life (T-HALF) of Urelumab (BMS-663513)
Time frame: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years
Total body clearance (CLT) of Urelumab (BMS-663513)
Time frame: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stanford University Medical Center
Stanford, California, United States
University Of Chicago
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Providence Portland Med Ctr
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
...and 14 more locations
Volume of distribution at steady-state (Vss) of Urelumab (BMS-663513)
Time frame: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years
Human Anti-human Antibodies
Immunogenicity of Urelumab (BMS-663513), as determined by blood sample measurements of human antihuman antibodies (HAHA)
Time frame: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years
Tumor response and progression as determined by proportion of patients with best overall response (BOR), progression-free survival (PFS), objective response rate (ORR), time to response, and duration of response
Time frame: 9 weeks from Baseline (Day 1) and every 9 weeks until disease progression, death or last tumor assessment (Approximately up to 2 years)