This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
380
MEDI4736 is administered by IV infusion in combination with tremelimumab
Tremelimumab is administered by IV infusion in combination with MEDI4736
Number of subjects reporting adverse events
Time frame: Screening through 15 months after the last subject enters re-treatment
Number of subjects reporting serious adverse events
Time frame: Screening through 15 months after the last subject enters re-treatment
Number of subjects experiencing a dose-limiting toxicity
Time frame: First dose of study medication through 4 weeks after the first dose of study medication
Change from Baseline in laboratory evaluations
Time frame: Screening through 3 months after the last dose of study medication
Change from Baseline in vital signs
Time frame: Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiogram evaluations
Time frame: Screening through 3 months after the last dose of study medication
Overall Response Rate in Select Tumor Types
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Overall Response Rate
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Disease Control Rate
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Duration of Response
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Research Site
Scottsdale, Arizona, United States
Research Site
Duarte, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Whittier, California, United States
Research Site
Aurora, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Miami Beach, Florida, United States
Research Site
Tampa, Florida, United States
...and 65 more locations
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Progression-Free Survival
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Overall Survival
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Individual MEDI4736 concentrations
Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Individual tremelimumab concentrations
Time frame: First dose of tremelimumab through 3 months after the last dose of study medication
MEDI4736 area under the concentration-curve
Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Tremelimumab area under the concentration-curve
Time frame: First dose of tremelimumab through 3 months after the last dose of study medication
Number of subjects that develop detectable antidrug antibodies to MEDI4736
Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Number of subjects that develop antidrug antibodies to tremelimumab
Time frame: First dose of tremelimumab through 3 months after the last dose of study medication