2019
First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1
Somaiah N, Block MS, Kim JW, Shapiro GI, T. K, Hwu P, Eder J, Jones RL, Lu H, Meulen J, Bohac C, Chen M, Hsu FJ, Gnjatic S, Pollack SM. First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1. Clinical Cancer Research 2019, 25: 5808-5817. PMID: 31227504, DOI: 10.1158/1078-0432.ccr-19-1025.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsAdverse eventsDendritic cellsSarcoma patientsImmune responseCommon treatment-related adverse eventsNY-ESO-1 immune responsesNY-ESO-1-expressing tumorsSolid tumorsLimited tumor burdenDisease control rateInjection site reactionsNY-ESO-1Potential clinical activityFavorable safety profileAntigen-specific responsesCancer-testis antigensAnti-NYDose cohortsPartial responseAdvanced cancerTumor burdenSafety profileSynovial sarcomaControl rateDissecting alterations in human CD8+ T cells with aging by high-dimensional single cell mass cytometry
Shin MS, Yim K, Moon K, Park HJ, Mohanty S, Kim JW, Montgomery RR, Shaw AC, Krishnaswamy S, Kang I. Dissecting alterations in human CD8+ T cells with aging by high-dimensional single cell mass cytometry. Clinical Immunology 2019, 200: 24-30. PMID: 30659916, PMCID: PMC6443094, DOI: 10.1016/j.clim.2019.01.005.Peer-Reviewed Original ResearchFirst-in-Human Phase I Trial of a Tumor-Targeted Cytokine (NHS-IL12) in Subjects with Metastatic Solid Tumors
Strauss J, Heery CR, Kim JW, Jochems C, Donahue RN, Montgomery AS, McMahon S, Lamping E, Marté J, Madan RA, Bilusic M, Silver MR, Bertotti E, Schlom J, Gulley JL. First-in-Human Phase I Trial of a Tumor-Targeted Cytokine (NHS-IL12) in Subjects with Metastatic Solid Tumors. Clinical Cancer Research 2019, 25: 99-109. PMID: 30131389, PMCID: PMC6320276, DOI: 10.1158/1078-0432.ccr-18-1512.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedCell Line, TumorDNA FragmentationDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunoglobulin GInfluenza, HumanInterleukin-12Killer Cells, NaturalLymphocytes, Tumor-InfiltratingMaleMaximum Tolerated DoseMiddle AgedNatural Killer T-CellsNeoplasmsNeoplasms, Second PrimaryReceptors, Antigen, T-CellRecombinant Fusion ProteinsTransaminasesConceptsTreatment-related adverse eventsAscending dose cohortsNHS-IL12Solid tumorsT-cell receptor sequencing analysisHuman phase I trialMultiple ascending dose cohortsSingle ascending dose (SAD) cohortsTumor-infiltrating lymphocyte densityPeripheral blood mononuclear cellsPeripheral immune cell subsetsDurable stable diseaseImmune checkpoint inhibitorsObjective tumor responsePhase II doseT-cell receptor diversityAdvanced solid tumorsFlu-like symptomsMetastatic solid tumorsPhase I trialNatural killer cellsImmune cell subsetsBlood mononuclear cellsWarrants further studyEnhanced antitumor activity
2018
CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer
Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. Journal Of Clinical Oncology 2018, 36: 2836-2844. PMID: 30110194, PMCID: PMC6161834, DOI: 10.1200/jco.2017.76.6212.Peer-Reviewed Original ResearchConceptsObjective response rateGastroesophageal junction cancerEsophagogastric cancerJunction cancerOverall survivalTreatment-related grade 3/4 adverse eventsInvestigator-assessed objective response rateResponse rateGrade 3/4 adverse eventsProgression-free survival ratesEfficacy of nivolumabLong-term OSMeaningful antitumor activityMetastatic esophagogastric cancerMore prior therapiesNivolumab Plus IpilimumabSafety of nivolumabManageable safety profilePrimary end pointSecond-line chemotherapySuperior overall survivalPhase III studyAssociation of tumorPrior therapyData cutoffAtezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study
Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O’Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncology 2018, 4: 537-544. PMID: 29423515, PMCID: PMC5885219, DOI: 10.1001/jamaoncol.2017.5440.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Transitional CellCohort StudiesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisSurvival AnalysisTime FactorsUrinary Bladder NeoplasmsUrotheliumConceptsDeath ligand 1 (PD-L1) expressionMedian overall survivalMetastatic urothelial carcinomaLigand 1 expressionProgression-free survivalPhase 1 studyOverall survivalAdverse eventsClinical benefitUrothelial carcinomaImmune cellsEastern Cooperative Oncology Group performance status 0Long-term clinical profilesMedian progression-free survivalSerious related adverse eventsSolid Tumors version 1.1Treatment-related adverse eventsLong-term clinical outcomesTumor-infiltrating immune cellsPerformance status 0Treatment-related deathsUnacceptable toxic effectsMetastatic urothelial cancerObjective response rateThird-line therapy
2016
Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial
Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. The Lancet Oncology 2016, 17: 1590-1598. PMID: 27733243, PMCID: PMC5648054, DOI: 10.1016/s1470-2045(16)30496-x.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaTreatment-related adverse eventsAdvanced urothelial carcinomaSerious adverse eventsPlatinum-based chemotherapyUrothelial carcinomaAdverse eventsNivolumab monotherapyObjective responseInvestigator-assessed objective responsePrevious platinum-based chemotherapyProtocol-defined reasonsSafety of nivolumabManageable safety profileOpen-label studyPD-L1 expressionDurable clinical responsesDose of treatmentBristol-Myers SquibbCheckMate 032Data cutoffElevated lipaseMonotherapy groupPrimary endpointStudy drugProspective Study Evaluating Na18F PET/CT in Predicting Clinical Outcomes and Survival in Advanced Prostate Cancer
Apolo AB, Lindenberg L, Shih JH, Mena E, Kim JW, Park JC, Alikhani A, McKinney YY, Weaver J, Turkbey B, Parnes HL, Wood LV, Madan RA, Gulley JL, Dahut WL, Kurdziel KA, Choyke PL. Prospective Study Evaluating Na18F PET/CT in Predicting Clinical Outcomes and Survival in Advanced Prostate Cancer. Journal Of Nuclear Medicine 2016, 57: 886-892. PMID: 26795292, PMCID: PMC6599519, DOI: 10.2967/jnumed.115.166512.Peer-Reviewed Original ResearchConceptsPET/CTAdvanced prostate cancerOverall survivalClinical impressionBone metastasesNumber of lesionsClinical outcomesProstate cancerMalignant lesionsMethylene diphosphonate bone scanProstate-specific antigen (PSA) changesPercentage changeMore bone metastasesDiphosphonate bone scanHigh-risk patientsProspective pilot studyPredicting Clinical OutcomesProstate cancer patientsMaximal percentage changeBone scanAntigen changesCancer patientsPositive lesionsBone diseaseMore lesions
2005
A phase I trial of surgery, Gliadel wafer implantation, and immediate postoperative carboplatin in combination with radiation therapy for primary anaplastic astrocytoma or glioblastoma multiforme
Limentani SA, Asher A, Heafner M, Kim JW, Fraser R. A phase I trial of surgery, Gliadel wafer implantation, and immediate postoperative carboplatin in combination with radiation therapy for primary anaplastic astrocytoma or glioblastoma multiforme. Journal Of Neuro-Oncology 2005, 72: 241-244. PMID: 15937647, DOI: 10.1007/s11060-004-2339-1.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Agents, AlkylatingAstrocytomaBrain NeoplasmsCarboplatinCarmustineCombined Modality TherapyDecanoic AcidsDisease ProgressionDrug ImplantsDrug Therapy, CombinationFemaleGlioblastomaHumansMaleMiddle AgedNeoplasm StagingNeurosurgical ProceduresPolyestersSurvival Analysis