Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies

Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q...
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Autor*in:	Aung Naing [verfasserIn] Jeffrey Infante [verfasserIn] Sanjay Goel [verfasserIn] Howard Burris [verfasserIn] Chelsea Black [verfasserIn] Shannon Marshall [verfasserIn] Ikbel Achour [verfasserIn] Susannah Barbee [verfasserIn] Rena May [verfasserIn] Chris Morehouse [verfasserIn] Kristen Pollizzi [verfasserIn] Xuyang Song [verfasserIn] Keith Steele [verfasserIn] Nairouz Elgeioushi [verfasserIn] Farzana Walcott [verfasserIn] Joyson Karakunnel [verfasserIn] Patricia LoRusso [verfasserIn] Amy Weise [verfasserIn] Joseph Eder [verfasserIn] Brendan Curti [verfasserIn] Michael Oberst [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma

Übergeordnetes Werk:	In: Journal for ImmunoTherapy of Cancer - BMJ Publishing Group, 2013, 7(2019), 1, Seite 15
Übergeordnetes Werk:	volume:7 ; year:2019 ; number:1 ; pages:15

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/s40425-019-0665-2

Katalog-ID:	DOAJ002219565

Internformat


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520			\|a Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013.
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650		4	\|a Kidney cancer
650		4	\|a Melanoma
653		0	\|a Neoplasms. Tumors. Oncology. Including cancer and carcinogens
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700	0		\|a Shannon Marshall \|e verfasserin \|4 aut
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700	0		\|a Xuyang Song \|e verfasserin \|4 aut
700	0		\|a Keith Steele \|e verfasserin \|4 aut
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allfields	10.1186/s40425-019-0665-2 doi (DE-627)DOAJ002219565 (DE-599)DOAJcf9d82e0ebcd4aaeac76ef9a975cf4f7 DE-627 ger DE-627 rakwb eng RC254-282 Aung Naing verfasserin aut Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013. MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jeffrey Infante verfasserin aut Sanjay Goel verfasserin aut Howard Burris verfasserin aut Chelsea Black verfasserin aut Shannon Marshall verfasserin aut Ikbel Achour verfasserin aut Susannah Barbee verfasserin aut Rena May verfasserin aut Chris Morehouse verfasserin aut Kristen Pollizzi verfasserin aut Xuyang Song verfasserin aut Keith Steele verfasserin aut Nairouz Elgeioushi verfasserin aut Farzana Walcott verfasserin aut Joyson Karakunnel verfasserin aut Patricia LoRusso verfasserin aut Amy Weise verfasserin aut Joseph Eder verfasserin aut Brendan Curti verfasserin aut Michael Oberst verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 7(2019), 1, Seite 15 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:7 year:2019 number:1 pages:15 https://doi.org/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/article/cf9d82e0ebcd4aaeac76ef9a975cf4f7 kostenfrei http://link.springer.com/article/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 15
spelling	10.1186/s40425-019-0665-2 doi (DE-627)DOAJ002219565 (DE-599)DOAJcf9d82e0ebcd4aaeac76ef9a975cf4f7 DE-627 ger DE-627 rakwb eng RC254-282 Aung Naing verfasserin aut Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013. MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jeffrey Infante verfasserin aut Sanjay Goel verfasserin aut Howard Burris verfasserin aut Chelsea Black verfasserin aut Shannon Marshall verfasserin aut Ikbel Achour verfasserin aut Susannah Barbee verfasserin aut Rena May verfasserin aut Chris Morehouse verfasserin aut Kristen Pollizzi verfasserin aut Xuyang Song verfasserin aut Keith Steele verfasserin aut Nairouz Elgeioushi verfasserin aut Farzana Walcott verfasserin aut Joyson Karakunnel verfasserin aut Patricia LoRusso verfasserin aut Amy Weise verfasserin aut Joseph Eder verfasserin aut Brendan Curti verfasserin aut Michael Oberst verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 7(2019), 1, Seite 15 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:7 year:2019 number:1 pages:15 https://doi.org/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/article/cf9d82e0ebcd4aaeac76ef9a975cf4f7 kostenfrei http://link.springer.com/article/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 15
allfields_unstemmed	10.1186/s40425-019-0665-2 doi (DE-627)DOAJ002219565 (DE-599)DOAJcf9d82e0ebcd4aaeac76ef9a975cf4f7 DE-627 ger DE-627 rakwb eng RC254-282 Aung Naing verfasserin aut Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013. MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jeffrey Infante verfasserin aut Sanjay Goel verfasserin aut Howard Burris verfasserin aut Chelsea Black verfasserin aut Shannon Marshall verfasserin aut Ikbel Achour verfasserin aut Susannah Barbee verfasserin aut Rena May verfasserin aut Chris Morehouse verfasserin aut Kristen Pollizzi verfasserin aut Xuyang Song verfasserin aut Keith Steele verfasserin aut Nairouz Elgeioushi verfasserin aut Farzana Walcott verfasserin aut Joyson Karakunnel verfasserin aut Patricia LoRusso verfasserin aut Amy Weise verfasserin aut Joseph Eder verfasserin aut Brendan Curti verfasserin aut Michael Oberst verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 7(2019), 1, Seite 15 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:7 year:2019 number:1 pages:15 https://doi.org/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/article/cf9d82e0ebcd4aaeac76ef9a975cf4f7 kostenfrei http://link.springer.com/article/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 15
allfieldsGer	10.1186/s40425-019-0665-2 doi (DE-627)DOAJ002219565 (DE-599)DOAJcf9d82e0ebcd4aaeac76ef9a975cf4f7 DE-627 ger DE-627 rakwb eng RC254-282 Aung Naing verfasserin aut Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013. MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jeffrey Infante verfasserin aut Sanjay Goel verfasserin aut Howard Burris verfasserin aut Chelsea Black verfasserin aut Shannon Marshall verfasserin aut Ikbel Achour verfasserin aut Susannah Barbee verfasserin aut Rena May verfasserin aut Chris Morehouse verfasserin aut Kristen Pollizzi verfasserin aut Xuyang Song verfasserin aut Keith Steele verfasserin aut Nairouz Elgeioushi verfasserin aut Farzana Walcott verfasserin aut Joyson Karakunnel verfasserin aut Patricia LoRusso verfasserin aut Amy Weise verfasserin aut Joseph Eder verfasserin aut Brendan Curti verfasserin aut Michael Oberst verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 7(2019), 1, Seite 15 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:7 year:2019 number:1 pages:15 https://doi.org/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/article/cf9d82e0ebcd4aaeac76ef9a975cf4f7 kostenfrei http://link.springer.com/article/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 15
allfieldsSound	10.1186/s40425-019-0665-2 doi (DE-627)DOAJ002219565 (DE-599)DOAJcf9d82e0ebcd4aaeac76ef9a975cf4f7 DE-627 ger DE-627 rakwb eng RC254-282 Aung Naing verfasserin aut Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013. MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jeffrey Infante verfasserin aut Sanjay Goel verfasserin aut Howard Burris verfasserin aut Chelsea Black verfasserin aut Shannon Marshall verfasserin aut Ikbel Achour verfasserin aut Susannah Barbee verfasserin aut Rena May verfasserin aut Chris Morehouse verfasserin aut Kristen Pollizzi verfasserin aut Xuyang Song verfasserin aut Keith Steele verfasserin aut Nairouz Elgeioushi verfasserin aut Farzana Walcott verfasserin aut Joyson Karakunnel verfasserin aut Patricia LoRusso verfasserin aut Amy Weise verfasserin aut Joseph Eder verfasserin aut Brendan Curti verfasserin aut Michael Oberst verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 7(2019), 1, Seite 15 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:7 year:2019 number:1 pages:15 https://doi.org/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/article/cf9d82e0ebcd4aaeac76ef9a975cf4f7 kostenfrei http://link.springer.com/article/10.1186/s40425-019-0665-2 kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 15
language	English
source	In Journal for ImmunoTherapy of Cancer 7(2019), 1, Seite 15 volume:7 year:2019 number:1 pages:15
sourceStr	In Journal for ImmunoTherapy of Cancer 7(2019), 1, Seite 15 volume:7 year:2019 number:1 pages:15
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma Neoplasms. Tumors. Oncology. Including cancer and carcinogens
isfreeaccess_bool	true
container_title	Journal for ImmunoTherapy of Cancer
authorswithroles_txt_mv	Aung Naing @@aut@@ Jeffrey Infante @@aut@@ Sanjay Goel @@aut@@ Howard Burris @@aut@@ Chelsea Black @@aut@@ Shannon Marshall @@aut@@ Ikbel Achour @@aut@@ Susannah Barbee @@aut@@ Rena May @@aut@@ Chris Morehouse @@aut@@ Kristen Pollizzi @@aut@@ Xuyang Song @@aut@@ Keith Steele @@aut@@ Nairouz Elgeioushi @@aut@@ Farzana Walcott @@aut@@ Joyson Karakunnel @@aut@@ Patricia LoRusso @@aut@@ Amy Weise @@aut@@ Joseph Eder @@aut@@ Brendan Curti @@aut@@ Michael Oberst @@aut@@
publishDateDaySort_date	2019-01-01T00:00:00Z
hierarchy_top_id	750086335
id	DOAJ002219565
language_de	englisch
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callnumber-first	R - Medicine
author	Aung Naing
spellingShingle	Aung Naing misc RC254-282 misc MEDI0680 misc PD-1 misc Immunotherapy misc Kidney cancer misc Melanoma misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies
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topic_title	RC254-282 Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies MEDI0680 PD-1 Immunotherapy Kidney cancer Melanoma
topic	misc RC254-282 misc MEDI0680 misc PD-1 misc Immunotherapy misc Kidney cancer misc Melanoma misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
topic_unstemmed	misc RC254-282 misc MEDI0680 misc PD-1 misc Immunotherapy misc Kidney cancer misc Melanoma misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
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title	Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies
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title_full	Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies
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author_browse	Aung Naing Jeffrey Infante Sanjay Goel Howard Burris Chelsea Black Shannon Marshall Ikbel Achour Susannah Barbee Rena May Chris Morehouse Kristen Pollizzi Xuyang Song Keith Steele Nairouz Elgeioushi Farzana Walcott Joyson Karakunnel Patricia LoRusso Amy Weise Joseph Eder Brendan Curti Michael Oberst
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title_sort	anti-pd-1 monoclonal antibody medi0680 in a phase i study of patients with advanced solid malignancies
callnumber	RC254-282
title_auth	Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies
abstract	Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013.
abstractGer	Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013.
abstract_unstemmed	Abstract Background The safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies. Methods MEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics. Results Fifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts. Conclusions MEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration. Trial registration NCT02013804; date of registration December 12, 2013.
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title_short	Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies
url	https://doi.org/10.1186/s40425-019-0665-2 https://doaj.org/article/cf9d82e0ebcd4aaeac76ef9a975cf4f7 http://link.springer.com/article/10.1186/s40425-019-0665-2 https://doaj.org/toc/2051-1426
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author2	Jeffrey Infante Sanjay Goel Howard Burris Chelsea Black Shannon Marshall Ikbel Achour Susannah Barbee Rena May Chris Morehouse Kristen Pollizzi Xuyang Song Keith Steele Nairouz Elgeioushi Farzana Walcott Joyson Karakunnel Patricia LoRusso Amy Weise Joseph Eder Brendan Curti Michael Oberst
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Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies

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