This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
15 mg/kg IV every 3 months as long as required
Research Site
Los Angeles, California, United States
Research Site
Tampa, Florida, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
Houston, Texas, United States
Research Site
Newecastle Upon Tyne, United Kingdom
Safety Endpoints: Serious Adverse Events to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Survival
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Disease Free Survival
Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
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