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Biomarker, Clinical, P1 data, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO Biomarker: Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 (BMS-936559). (Pubmed Central) - Feb 20, 2020 In this first clinical evaluation of programmed cell death protein-1/programmed cell death-ligand 1 pathway inhibition in sepsis, BMS-936559 was well tolerated, with no evidence of drug-induced hypercytokinemia or cytokine storm, and at higher doses, some indication of restored immune status over 28 days. Further randomized trials on programmed cell death protein-1/programmed cell death-ligand 1 pathway inhibition are needed to evaluate its clinical safety and efficacy in patients with sepsis.
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Journal: Immunotherapy in Lung Cancer: A New Age in Cancer Treatment. (Pubmed Central) - Jun 4, 2019 It also analyzes the different studies that have been developed for NSCLC with these medications, the evidence obtained, and the possible role in the management of patients. Immunotherapy has definitely changed the paradigm on NSCLC treatment, and the future is promising for the benefit of patients.
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Enrollment closed, Enrollment change, Trial primary completion date, PD(L)-1 Biomarker, IO biomarker: Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis (clinicaltrials.gov) - Aug 2, 2017 P1b/2a, N=35, Active, not recruiting, Active, not recruiting --> Terminated; Business Objectives Have Changed Recruiting --> Active, not recruiting | N=225 --> 35 | Trial primary completion date: Jun 2018 --> Mar 2017
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Trial primary completion date, PD(L)-1 Biomarker, IO biomarker: Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis (clinicaltrials.gov) - Jul 19, 2016 P1b/2a, N=225, Recruiting, Recruiting --> Active, not recruiting | N=225 --> 35 | Trial primary completion date: Jun 2018 --> Mar 2017 Trial primary completion date: Sep 2018 --> Jun 2018
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Trial completion, PD(L)-1 Biomarker, Metastases: Multiple Ascending Dose (MDX1105-01) (clinicaltrials.gov) - Sep 8, 2015 P1, N=281, Completed, Suspended --> Completed | N=56 --> 8 | Trial primary completion date: May 2016 --> Nov 2015 Active, not recruiting --> Completed
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Trial primary completion date, PD(L)-1 Biomarker, Metastases: Multiple Ascending Dose (MDX1105-01) (clinicaltrials.gov) - Apr 28, 2015 P1, N=286, Active, not recruiting, Active, not recruiting --> Completed Trial primary completion date: Jan 2015 --> Jul 2015
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Trial primary completion date, PD(L)-1 Biomarker, Metastases: Multiple Ascending Dose (MDX1105-01) (clinicaltrials.gov) - May 6, 2014 P1, N=286, Active, not recruiting, Not yet recruiting --> Recruiting Trial primary completion date: Dec 2013 --> Jan 2015
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Trial completion date, PD(L)-1 Biomarker, Metastases: Multiple Ascending Dose (MDX1105-01) (clinicaltrials.gov) - May 6, 2014 P1, N=286, Active, not recruiting, Trial primary completion date: Dec 2013 --> Jan 2015 Trial completion date: Dec 2013 --> Jan 2015
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Trial initiation date, PD(L)-1 Biomarker, Metastases: Multiple Ascending Dose (MDX1105-01) (clinicaltrials.gov) - May 6, 2014 P1, N=286, Active, not recruiting, Trial completion date: Dec 2013 --> Jan 2015 Initiation date: Jan 1975 --> Apr 2009
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Enrollment closed, PD(L)-1 Biomarker, Metastases: Multiple Ascending Dose (MDX1105-01) (clinicaltrials.gov) - Mar 13, 2013 P1, N=286, Active, not recruiting, Initiation date: Jan 1975 --> Apr 2009 Recruiting --> Active, not recruiting
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