This is a multicenter, open-label, first-time-in-human study with a standard 3+3
dose-escalation phase in participants with advanced solid tumors followed by an expansion
phase in participants with advanced solid tumors. An exploration cohort has been added to
determine the safety using every 4 weeks (Q4W) dosing.
A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab
Completed
Cancer Research Institute, New York City
Phase 1
2013-12-19
This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and
tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed
standard treatment. The primary study objective was to determine the maximum tolerated dose
(MTD) and safety profile of the durvalumab and tremelimumab combination. Secondary objectives
were to evaluate the pharmacokinetics (PK) and immunogenicity of durvalumab and tremelimumab,
and the antitumor activity (tumor response, progression-free survival [PFS], and overall
survival [OS]) of the durvalumab and tremelimumab combination. (Note: Collection of PK and
immunogenicity samples was removed by amendment; analysis was not done.) Exploratory
objectives were to evaluate the biological activity of the durvalumab and tremelimumab
combination.
A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab
Completed
MedImmune LLC
Phase 1
2013-12-19
This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and
tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed
standard treatment. The primary study objective was to determine the maximum tolerated dose
(MTD) and safety profile of the durvalumab and tremelimumab combination. Secondary objectives
were to evaluate the pharmacokinetics (PK) and immunogenicity of durvalumab and tremelimumab,
and the antitumor activity (tumor response, progression-free survival [PFS], and overall
survival [OS]) of the durvalumab and tremelimumab combination. (Note: Collection of PK and
immunogenicity samples was removed by amendment; analysis was not done.) Exploratory
objectives were to evaluate the biological activity of the durvalumab and tremelimumab
combination.
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