2016
Atezolizumab, an Anti–Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study
McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, Powderly JD, Infante JR, Fassò M, Wang YV, Zou W, Hegde PS, Fine GD, Powles T. Atezolizumab, an Anti–Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. Journal Of Clinical Oncology 2016, 34: 833-842. PMID: 26755520, DOI: 10.1200/jco.2015.63.7421.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkers, TumorCarcinoma, Renal CellDose-Response Relationship, DrugDose-Response Relationship, ImmunologicFemaleHumansImmunohistochemistryKidney NeoplasmsLymphocytes, Tumor-InfiltratingMaleMiddle AgedT-LymphocytesConceptsMetastatic renal cell carcinomaRenal cell carcinomaClinical activityCell carcinomaImmune cellsAnti-programmed death ligand 1 antibodyImmune-mediated adverse eventsNon-clear cell histologySolid Tumors version 1.1Death ligand 1 antibodyTumor-infiltrating immune cellsEnd pointFuhrman grade 4Phase Ia studyManageable safety profileObjective response ratePrimary end pointSecondary end pointsPD-L1 expressionPD-L1 stainingProgression-free survivalResponse Evaluation CriteriaEffector T cellsAcute phase proteinsGrade 4
2013
Nivolumab plus Ipilimumab in Advanced Melanoma
Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A, Kronenberg SA, Agunwamba BU, Zhang X, Lowy I, Inzunza HD, Feely W, Horak CE, Hong Q, Korman AJ, Wigginton JM, Gupta A, Sznol M. Nivolumab plus Ipilimumab in Advanced Melanoma. New England Journal Of Medicine 2013, 369: 122-133. PMID: 23724867, PMCID: PMC5698004, DOI: 10.1056/nejmoa1302369.Peer-Reviewed Original ResearchConceptsObjective response ratePhase 1 trialAdverse eventsConcurrent therapyAdvanced melanomaTumor regressionClinical activityGrade 3Distinct immunologic mechanismsManageable safety profileProlongs overall survivalDurable tumor regressionSupportive preclinical dataRegimen groupImmunologic mechanismsObjective responseOverall survivalIntravenous dosesSafety profileTumor reductionPreclinical dataIpilimumabNivolumabPatientsMaximum doses