This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
655
decarbazine 1000 mg/m2 IV Q 21 days x 12
CP-675,206 15 mg/kg IV Q 90 days x 4
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
overall survival
Time frame: August 2010
adverse events
Time frame: 1 year
PFS at 6 months
Time frame: 6 months
objective tumor response
Time frame: 1 year
Durable response
Time frame: 6 months
pharmacokinetics endpoints
Time frame: 15 months
pharmacogenomic endpoints
Time frame: 1 year
HQol
Time frame: 1 year
healthcare resource utilization and loss of productivity
Time frame: 1 year
human antihuman antibody response for patients in Arm A
Time frame: 15 months
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Research Site
Huntsville, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Bakersfield, California, United States
Research Site
Corona, California, United States
Research Site
Fullerton, California, United States
Research Site
Glendora, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Long Beach, California, United States
...and 133 more locations