2019
Prospective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer.
Jabbour S, Berman A, Decker R, Lin Y, Feigenberg S, Gettinger S, Aggarwal C, Langer C, Simone C, Bradley J, Aisner J, Malhotra J. Prospective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer. Journal Of Clinical Oncology 2019, 37: 8511-8511. DOI: 10.1200/jco.2019.37.15_suppl.8511.Peer-Reviewed Original ResearchImmune-related adverse eventsStage III NSCLCDose limiting toxicitiesChemoradiation therapyPD-1iDay 29Unresectable non-small cell lung cancerDay 1Prospective phase I clinical trialNon-small cell lung cancerDeath ligand 1 (PD-L1) inhibitionPhase I clinical trialDefinitive chemoradiation therapyGrade 3 hyperglycemiaPD-1 blockadeFurther prospective studiesCell lung cancerMulti-institutional trialDose cohortsMedian PFSQ3 weeksConcurrent chemoradiationDefinitive RTAdverse eventsInterstitial nephritis
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