The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
IV solution, IV, until PD or toxicity
Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
Time frame: every 6 weeks starting at week 12 after randomization
Safety profiles
Time frame: throughout the study
Disease response rate
Time frame: end of study
Disease control rate
Time frame: end of study
1-year survival
Time frame: end of study
Pharmacokinetics
Time frame: throughout the study
Pharmacodynamics
Time frame: throughout the study
Biomarkers
Time frame: throughout the study
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The Angeles Clinic & Research Institute
Los Angeles, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Indiana University Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States
Harry & Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, United States
Dana-Farber Cancer Inst
Boston, Massachusetts, United States
Mem Sloan-Ket Can Ctr
New York, New York, United States
Blumenthal Cancer Center, Carolinas Medical Center
Charlotte, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
University Of Texas
Houston, Texas, United States
...and 22 more locations