CLINICAL TRIALS PROFILE FOR DURVALUMAB
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All Clinical Trials for durvalumab
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT01693562 ↗ | A Phase 1/2 Study to Evaluate MEDI4736 | Completed | MedImmune LLC | Phase 1/Phase 2 | 2012-09-05 | 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. |
NCT01975831 ↗ | 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. |
NCT01975831 ↗ | 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. |
NCT01975831 ↗ | A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab | Completed | Ludwig Institute for Cancer Research | 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. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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