The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Local Institution
Los Angeles, California, United States
Local Institution
New Haven, Connecticut, United States
Local Institution
Tampa, Florida, United States
Local Institution
Boston, Massachusetts, United States
Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests
Time frame: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received
Evidence of clinical improvement in tumor burden confirmed by CT or MRI
Time frame: Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter
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Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Local Institution
Boston, Massachusetts, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
New York, New York, United States