2013
A phase I study of nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus platinum-based doublet chemotherapy (PT-doublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts).
Rizvi N, Antonia S, Chow L, Brahmer J, Juergens R, Borghaei H, Shepherd F, Laurie S, Gerber D, Goldman J, Shen Y, Harbison C, Alaparthy S, Chen A, Gettinger S. A phase I study of nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus platinum-based doublet chemotherapy (PT-doublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts). Journal Of Clinical Oncology 2013, 31: 8072-8072. DOI: 10.1200/jco.2013.31.15_suppl.8072.Peer-Reviewed Original ResearchNSCLC ptsArm APhase INon-small cell lung cancer patientsPlatinum-based doublet chemotherapyCell lung cancer patientsCarboplatin/paclitaxelIncidence of DLTTolerable safety profileGemcitabine/cisplatinLung cancer patientsDe-escalation designWk of dosingGr 3Doublet chemotherapyNivolumab dosesStandard dosingAspergillus pneumoniaChemotherapy regimenDose cohortsDurable responsesArm BMaintenance treatmentConfirmation of responseSafety profileSurvival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Sankar V, Ahlers C, Wigginton J, Kollia G, Gupta A, Gettinger S. Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8030-8030. DOI: 10.1200/jco.2013.31.15_suppl.8030.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase I trialOverall survivalMedian OSI trialCommon drug-related AEsDrug-related AEsMedian overall survivalPrior chemotherapy regimenAcceptable safety profilePhase 1 studyCell lung cancerPD-1 receptorImmune checkpoint receptorsDrug-related deathsT cell activationNSCLC ptsOS benefitChemotherapy regimenDose cohortsCheckpoint receptorsDeath-1Safety profileDiscontinuation criteria
2012
Clinical activity and safety of anti-PD1 (BMS-936558, MDX-1106) in patients with advanced non-small-cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Wigginton J, McDonald D, Kollia G, Gupta A, Gettinger S. Clinical activity and safety of anti-PD1 (BMS-936558, MDX-1106) in patients with advanced non-small-cell lung cancer (NSCLC). Journal Of Clinical Oncology 2012, 30: 7509-7509. DOI: 10.1200/jco.2012.30.15_suppl.7509.Peer-Reviewed Original ResearchBMS-936558Advanced NSCLCClinical activityPrior tyrosine kinase inhibitorsPrior chemotherapy regimenECOG performance statusCo-inhibitory receptorsPlatinum-based chemotherapyCell lung cancerOverall tumor burdenCycles of treatmentPercent of ptsDrug-related deathsTyrosine kinase inhibitorsActivated T cellsCohort expansionNSCLC ptsPrior therapyRECIST 1.0Chemotherapy regimenMedian durationMetastatic diseaseMultiple histologiesPerformance statusLymph nodes
2009
A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors
Deshpande H, Gettinger S, Rowen E, Abu-Khalaf M, Clarke J, Burns A, Kelly W. A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors. Journal Of Clinical Oncology 2009, 27: e13501-e13501. DOI: 10.1200/jco.2009.27.15_suppl.e13501.Peer-Reviewed Original ResearchNanoparticle albumin-bound paclitaxelAlbumin-bound paclitaxelCohort 2Cohort 3Cohort 1Platinum agentsSolid tumorsDay 14Common severe adverse eventsGrade 3 anemiaMedian age 51Grade 4 neutropeniaStandard chemotherapy regimenAdvanced solid tumorsPhase 2 studySevere adverse eventsNeurological side effectsCycle 1Stable diseaseChemotherapy regimenDay 1 treatmentAdvanced malignanciesAdverse eventsPartial responseProgressive disease