To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Determine the safety profile of MDX 1411
Time frame: duration of study
Determine the maximum tolerated dose of MDX 1411
Time frame: duration of study
Determine the best overall response rate (BORR)
Time frame: Day 38-42 of each cycle
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Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States