CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
251
15 mg/kg Q12W dosing regimen
To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma
Time frame: Tumor response is assessed every 2-3 months until disease progression
Safety
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Pharmaco Kinetic
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Survival
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Health-related QoL
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
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Research Site
Scottsdale, Arizona, United States
Research Site
Bentonville, Arkansas, United States
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Fayetteville, Arkansas, United States
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Little Rock, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
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Aurora, Colorado, United States
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Stamford, Connecticut, United States
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Ocoee, Florida, United States
Research Site
Orlando, Florida, United States
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