The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Stanford University
Stanford, California, United States
University Of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events
As determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests During a 3 week cycle, safety labs are done on Days 1, 2, 3, 5, 8, and 15. Starting on Cycle 3, Day 1, Chemistry (excluding Liver function test (LFTs)) are to be performed on Day 1 and Day 15 of each cycle thereafter. Physical exams are done on Day 1 of each cycle. Vital signs are done on Days 1, 2, 8, and 15 at Cycle 1 and then on Days 1 and 2 of each cycle thereafter. Adverse events are collected from screening to 60 days after last dose of Urelumab
Time frame: Approximately 2 years
Objective response rate (ORR)
Time frame: Up to 2 years
Duration of Objective Response (DOR)
Time frame: Up to 2 years
Progression Free Survival (PFS)
Time frame: Up to 2 years
Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513
Time frame: Up to 2 years
Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Providence Oncology & Hematology Care Eastside
Portland, Oregon, United States
Upmc Cancer Center
Pittsburgh, Pennsylvania, United States
Time frame: Up to 2 years
Area under the serum concentration-time curve from time zero to the time of last quantifiable serum concentration (AUC(0-T)) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Total body clearance (CLT) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years