Survival and long-term follow-up of safety and response in patients (pts) with advanced melanoma (MEL) in a phase I trial of nivolumab (anti-PD-1; BMS-936558; ONO-4538).
Sznol M, Kluger H, Hodi F, McDermott D, Carvajal R, Lawrence D, Topalian S, Atkins M, Powderly J, Sharfman W, Puzanov I, Smith D, Wigginton J, Kollia G, Gupta A, Sosman J. Survival and long-term follow-up of safety and response in patients (pts) with advanced melanoma (MEL) in a phase I trial of nivolumab (anti-PD-1; BMS-936558; ONO-4538). Journal Of Clinical Oncology 2013, 31: cra9006-cra9006. DOI: 10.1200/jco.2013.31.18_suppl.cra9006.Peer-Reviewed Original ResearchPhase I trialI trialInhibitory immune checkpoint receptorsDrug-related AEsDrug-related diarrheaDrug-related pneumonitisAcceptable safety profilePhase III trialsOverall survival dataImmune checkpoint receptorsCycles of treatmentLong-term safetyMonoclonal antibody nivolumabActivated T cellsGr 3Cohort expansionECOG PSMedian OSPrior therapyIII trialsAdvanced melanomaAntibody nivolumabDose escalationPD-1Checkpoint receptorsSafety and clinical activity of nivolumab (anti-PD-1, BMS-936558, ONO-4538) in combination with ipilimumab in patients (pts) with advanced melanoma (MEL).
Wolchok J, Kluger H, Callahan M, Postow M, Gordon R, Segal N, Rizvi N, Lesokhin A, Reed K, Burke M, Caldwell A, Kronenberg S, Agunwamba B, Feely W, Hong Q, Horak C, Korman A, Wigginton J, Gupta A, Sznol M. Safety and clinical activity of nivolumab (anti-PD-1, BMS-936558, ONO-4538) in combination with ipilimumab in patients (pts) with advanced melanoma (MEL). Journal Of Clinical Oncology 2013, 31: 9012-9012. DOI: 10.1200/jco.2013.31.15_suppl.9012.Peer-Reviewed Original ResearchObjective response rateRelated adverse eventsPhase III trialsConcurrent therapyIII trialsPD-1Clinical activityCTLA-4/PDIpilimumab combination therapyCTLA-4 blockadeManageable safety profilePhase 1 studyPhase I trialImmune checkpoint receptorsIpilimumab therapyMonotherapy dataPrior therapySymptom resolutionAdverse eventsI trialAdvanced melanomaDurable CRCheckpoint receptorsSafety profileCombination therapySurvival, safety, and response duration results of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in a phase I trial in patients with previously treated metastatic renal cell carcinoma (mRCC): Long-term patient follow-up.
Drake C, McDermott D, Sznol M, Choueiri T, Kluger H, Powderly J, Smith D, Sankar V, Gutierrez A, Wigginton J, Kollia G, Gupta A, Atkins M. Survival, safety, and response duration results of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in a phase I trial in patients with previously treated metastatic renal cell carcinoma (mRCC): Long-term patient follow-up. Journal Of Clinical Oncology 2013, 31: 4514-4514. DOI: 10.1200/jco.2013.31.15_suppl.4514.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaOverall survivalDrug-related AEsGrade 3 pneumonitisMedian overall survivalAcceptable safety profilePhase III trialsPD-1 ligandsPhase I trialLong-term patientsPD-1 receptorImmune checkpoint receptorsRenal cell carcinomaLong-term safetyT cell activationPopulation of ptsPrior therapyTreatment discontinuationAdverse eventsIII trialsMedian durationUnacceptable toxicityComplete responseDeath-1I trial