The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Given intravenously every 3 months
As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
Research Site
Bentonville, Arkansas, United States
Research Site
Fayetteville, Arkansas, United States
Research Site
Orange, California, United States
Research Site
Danbury, Connecticut, United States
Research Site
Atlanta, Georgia, United States
Research Site
Lexington, Kentucky, United States
Research Site
Alexandria, Louisiana, United States
Research Site
New York, New York, United States
Research Site
Oneida, New York, United States
Research Site
Oswego, New York, United States
...and 16 more locations
The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
Time frame: 3 months to 2 years from randomization
Survival
Time frame: 2 years
Levels of study drug in blood samples taken at specified time points.
Time frame: up to 2 years
Whether polymorphisms of certain genes influence safety.
Time frame: up to 2 years
Health-related quality of life outcomes.
Time frame: up to 2 years
Tumor response
Time frame: up to 2 years
Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC
Time frame: up to 2 years
Blood levels of any human anti-human antibody response
Time frame: up to 2 years
Immune response.
Time frame: up to 2 years
Efficacy
Time frame: up to 2 years
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