2024
Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma
Long G, Larkin J, Schadendorf D, Grob J, Lao C, Márquez-Rodas I, Wagstaff J, Lebbé C, Pigozzo J, Robert C, Ascierto P, Atkinson V, Postow M, Atkins M, Sznol M, Callahan M, Topalian S, Sosman J, Kotapati S, Thakkar P, Ritchings C, Benito M, Re S, Soleymani S, Hodi F. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. Journal Of Clinical Oncology 2024, 43: 938-948. PMID: 39504507, PMCID: PMC11895829, DOI: 10.1200/jco.24.00400.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsPatients treated with nivolumabOverall survivalNivolumab monotherapyMultivariate analysisPD-L1Advanced melanomaPD-L1 expression levelsFactors associated with decreased survivalLong-term overall survivalPresence of liver metastasesCox proportional multivariate analysisFactors associated with survivalLactate dehydrogenaseClinical factors associated with survivalPD-L1 expressionTreatment naive patientsMedian Follow-UpElevated lactate dehydrogenaseCompany-sponsored trialsAssociated with survivalUnresectable/metastatic melanomaCheckpoint inhibitorsOS ratesTreatment decision makingIntratumoral T-cell infiltration and response to nivolumab plus ipilimumab in patients with metastatic clear cell renal cell carcinoma from the CheckMate-214 trial.
Matar S, Jegede O, Denize T, Ghandour F, Nabil Laimon Y, El Ahmar N, Bagheri Sheshdeh A, Savla V, Mohanna R, Catalano P, Braun D, Sun M, Gupta S, Vemula S, Freeman G, Motzer R, Atkins M, McDermott D, CHOUEIRI T, Signoretti S. Intratumoral T-cell infiltration and response to nivolumab plus ipilimumab in patients with metastatic clear cell renal cell carcinoma from the CheckMate-214 trial. Journal Of Clinical Oncology 2024, 42: 4536-4536. DOI: 10.1200/jco.2024.42.16_suppl.4536.Peer-Reviewed Original ResearchProgression-free survivalAssociated with progression-free survivalMultiplex immunofluorescenceClinical trialsClinical outcomesMetastatic clear cell renal cell carcinomaIntratumoral T cell infiltrationTreated with nivolumab monotherapyMetastatic clear cell RCCClear cell renal cell carcinomaResponse to nivolumabT cell infiltrationCell renal cell carcinomaPoor-risk patientsRenal cell carcinomaClear cell RCCFormalin Fixed ParaffinContinuous variablesNivolumab monotherapyCox proportional hazardsAntigen-experiencedCell RCCCell carcinomaLogistic regression modelsPositive associationSLAMF7+ CD8+ T cells exhibit decreased anti-tumor responses in renal cell carcinoma
Wirth L, Hugaboom M, Street K, Ruthen N, Jegede O, Schindler N, McDermott D, Plimack E, Sosman J, Haas N, Hurwitz M, Hammers H, Signoretti S, Atkins M, Wu C, Braun D. SLAMF7+ CD8+ T cells exhibit decreased anti-tumor responses in renal cell carcinoma. The Journal Of Immunology 2024, 212: 1491_5876-1491_5876. DOI: 10.4049/jimmunol.212.supp.1491.5876.Peer-Reviewed Original ResearchCD8+ T cellsImmune-checkpoint inhibitorsRenal cell carcinomaCD8+ T-cell effector functionT cell effector functionT cellsCell carcinomaResistance to immune-checkpoint inhibitorsEffector functionsPopulation of CD8+ T cellsCD3+ T cellsTreatment of renal cell carcinomaHealthy human PBMCTumor-infiltrating lymphocytesAnti-tumor responsesPatient T cellsReduction of pro-inflammatory cytokinesAnti-tumor functionPro-inflammatory cytokinesSingle-cell transcriptome analysisNivolumab monotherapySLAMF7 expressionClinical benefitGranzyme BIFN-gTreatment-free survival outcomes from the phase II study of nivolumab and salvage nivolumab/ipilimumab in advanced clear cell renal cell carcinoma (HCRN GU16-260-Cohort A)
Atkins M, Jegede O, Haas N, Mcdermott D, Bilen M, Stein M, Sosman J, Alter R, Plimack E, Ornstein M, Hurwitz M, Peace D, Einstein D, Catalano P, Hammers H, Regan M. Treatment-free survival outcomes from the phase II study of nivolumab and salvage nivolumab/ipilimumab in advanced clear cell renal cell carcinoma (HCRN GU16-260-Cohort A). Journal For ImmunoTherapy Of Cancer 2024, 12: e008293. PMID: 38604810, PMCID: PMC11015345, DOI: 10.1136/jitc-2023-008293.Peer-Reviewed Original ResearchConceptsTreatment-free survivalInternational Metastatic RCC Database ConsortiumFavorable-risk patientsNivolumab monotherapyPhase II study of nivolumabCessation of immunotherapyFavorable-risk diseaseProtocol therapy cessationStudy of nivolumabSystemic therapy initiationTreatment naive patientsPhase II studyRenal cell carcinomaKaplan-Meier curvesActive treatment approachPartitioned survival analysisCheckMate 067Stable diseaseProtocol therapyAdvanced melanomaTherapy initiationTreatment-freeCell carcinomaClear-cellProtocol treatment
2023
Ultrasensitive Circulating Tumor DNA Pilot Study Distinguishes Complete Response and Partial Response With Immunotherapy in Patients With Metastatic Renal Cell Carcinoma
Chehrazi-Raffle A, Muddasani R, Dizman N, Hsu J, Meza L, Zengin Z, Malhotra J, Chawla N, Dorff T, Contente-Cuomo T, Dinwiddie D, McDonald B, McDaniel T, Trent J, Baehner F, Murtaza M, Pal S. Ultrasensitive Circulating Tumor DNA Pilot Study Distinguishes Complete Response and Partial Response With Immunotherapy in Patients With Metastatic Renal Cell Carcinoma. JCO Precision Oncology 2023, 7: e2200543. PMID: 37027813, PMCID: PMC10309555, DOI: 10.1200/po.22.00543.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaPartial responseComplete responseVariant allele fractionRenal cell carcinomaCell carcinomaCtDNA analysisImmune checkpoint inhibitor therapyCheckpoint inhibitor therapyDiscontinuation of immunotherapyDepth of responseICI therapyNivolumab monotherapyEligible patientsRadiographic progressionInhibitor therapyPeripheral bloodDisease progressionCtDNA assessmentSubsequent progressionPatientsMultiple indicationsSingle time pointPatient-specific mutationsSecondary objectivePhase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naïve patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B)
Atkins M, Jegede O, Haas N, McDermott D, Bilen M, Stein M, Sosman J, Alter R, Plimack E, Ornstein M, Hurwitz M, Peace D, Signoretti S, Denize T, Cimadamore A, Wu C, Braun D, Einstein D, Catalano P, Hammers H. Phase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naïve patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B). Journal For ImmunoTherapy Of Cancer 2023, 11: e004780. PMID: 36948504, PMCID: PMC10040058, DOI: 10.1136/jitc-2022-004780.Peer-Reviewed Original ResearchConceptsNivolumab/ipilimumabObjective response rateNon-clear cell renal cell carcinomaTreatment-naïve patientsCell renal cell carcinomaProgressive diseaseRenal cell carcinomaNivolumab monotherapyStable diseaseCell carcinomaAdvanced non-clear cell renal cell carcinomaMedian progression-free survivalTreatment-related adverse eventsDeath ligand 1 (PD-L1) expressionLigand 1 expressionPhase II studyProgression-free survivalWeeks of treatmentSymptomatic disease progressionEligible patientsSalvage therapyB patientsII studySalvage treatmentSarcomatoid featuresTreatment-free survival (TFS) outcomes from the phase II study of nivolumab and salvage nivolumab + ipilimumab in advanced clear cell renal cell carcinoma (aRCC) (HCRN GU16-260-Cohort A).
Atkins M, Jegede O, McDermott D, Haas N, Bilen M, Stein M, Sosman J, Plimack E, Alter R, Ornstein M, Hurwitz M, Peace D, Einstein D, Catalano P, Hammers H, Regan M. Treatment-free survival (TFS) outcomes from the phase II study of nivolumab and salvage nivolumab + ipilimumab in advanced clear cell renal cell carcinoma (aRCC) (HCRN GU16-260-Cohort A). Journal Of Clinical Oncology 2023, 41: 604-604. DOI: 10.1200/jco.2023.41.6_suppl.604.Peer-Reviewed Original ResearchAdvanced clear cell renal cell carcinomaTreatment-related adverse eventsGrade 3Clear cell renal cell carcinomaActive treatment approachCheckMate 067 trialCheckMate 214 trialFurther anticancer therapyNivolumab/ipilimumabProlonged disease controlPhase II studyCell renal cell carcinomaKaplan-Meier curvesRenal cell carcinomaNivolumab monotherapyStable diseaseEligible patientsProtocol therapyTherapy initiationII studyTherapy cessationAdverse eventsSurvival outcomesCell carcinomaMetastatic melanoma
2022
Safety, tolerability and efficacy of agonist anti-CD27 antibody (varlilumab) administered in combination with anti-PD-1 (nivolumab) in advanced solid tumors
Sanborn RE, Pishvaian MJ, Callahan MK, Weise A, Sikic BI, Rahma O, Cho DC, Rizvi NA, Sznol M, Lutzky J, Bauman JE, Bitting RL, Starodub A, Jimeno A, Reardon DA, Kaley T, Iwamoto F, Baehring JM, Subramaniam DS, Aragon-Ching JB, Hawthorne TR, Rawls T, Yellin M, Keler T. Safety, tolerability and efficacy of agonist anti-CD27 antibody (varlilumab) administered in combination with anti-PD-1 (nivolumab) in advanced solid tumors. Journal For ImmunoTherapy Of Cancer 2022, 10: e005147. PMID: 35940825, PMCID: PMC9364417, DOI: 10.1136/jitc-2022-005147.Peer-Reviewed Original ResearchConceptsObjective response rateAnti-PD-1/L1Solid tumorsAnti-PD-1 therapyIntratumoral T cell infiltrationBetter progression-free survivalAnti-CD27 antibodyKey clinical endpointsTumor PD-L1Tumor-specific cohortsAdvanced solid tumorsProgression-free survivalRefractory solid tumorsOverall survival rateT cell infiltrationBetter clinical outcomesSquamous cell carcinomaOvarian cancer patientsPhase 2Phase 1Nivolumab monotherapyAdverse eventsImmune signaturesPD-L1Proinflammatory changesTranscriptomic Correlates of Tumor Cell PD-L1 Expression and Response to Nivolumab Monotherapy in Metastatic Clear Cell Renal Cell Carcinoma.
Denize T, Hou Y, Pignon J, Walton E, West D, Freeman G, Braun D, Wu C, Gupta S, Motzer R, Atkins M, McDermott D, Choueiri T, Shukla S, Signoretti S. Transcriptomic Correlates of Tumor Cell PD-L1 Expression and Response to Nivolumab Monotherapy in Metastatic Clear Cell Renal Cell Carcinoma. Clinical Cancer Research 2022, 28: 4045-4055. PMID: 35802667, PMCID: PMC9481706, DOI: 10.1158/1078-0432.ccr-22-0923.Peer-Reviewed Original ResearchConceptsTC PD-L1 expressionClear cell renal cell carcinomaPD-L1 expressionMetastatic clear cell renal cell carcinomaCell renal cell carcinomaRenal cell carcinomaProliferation-related pathwaysCell proliferation-related pathwaysClinical outcomesTumor cellsCell carcinomaTumor cell PD-L1 expressionAnti-PD-1 monotherapyPD-L1 positive tumorsHigher objective response rateLonger progression-free survivalTumor-infiltrating immune cellsTC PD-L1Objective response ratePD-L1 statusProgression-free survivalT-cell activation signaturesCheckMate 025 trialNivolumab monotherapyPD-L1
2021
Prolonged Complete Response of Early Stage Primary Adenocarcinoma of the Lung to Nivolumab Monotherapy.
Unlu S, Grant MJ, Gettinger S, Adeniran A, Kluger HM. Prolonged Complete Response of Early Stage Primary Adenocarcinoma of the Lung to Nivolumab Monotherapy. Clinical Oncology Case Reports 2021, 4 PMID: 34382032, PMCID: PMC8353529.Peer-Reviewed Original ResearchMultiple primary malignant tumorsNivolumab monotherapyCheckpoint inhibitorsLung cancerHigh Programmed-Death Ligand 1 (PD-L1) expressionProgrammed Death Ligand 1 ExpressionNon-small cell lung cancerMultiple regional lymph nodesImmune checkpoint inhibitorsPD-1 inhibitorsLigand 1 expressionPrimary lung cancerEarly-stage diseaseRegional lymph nodesCell lung cancerPrimary malignant tumorsHigh-risk natureSystemic immunotherapyDurable responsesAdvanced melanomaComplete responseEffective immunotherapyLymph nodesMore patientsPrimary adenocarcinoma
2018
LBA5 Efficacy and safety of nivolumab (nivo) monotherapy versus chemotherapy (chemo) in recurrent small cell lung cancer (SCLC): Results from CheckMate 331
Reck M, Vicente D, Ciuleanu T, Gettinger S, Peters S, Horn L, Audigier-Valette C, Pardo N, Juan-Vidal O, Cheng Y, Zhang H, Shi M, Wolf J, Antonia S, Nakagawa K, Selvaggi G, Baudelet C, Chang H, Spigel D. LBA5 Efficacy and safety of nivolumab (nivo) monotherapy versus chemotherapy (chemo) in recurrent small cell lung cancer (SCLC): Results from CheckMate 331. Annals Of Oncology 2018, 29: x43. DOI: 10.1093/annonc/mdy511.004.Peer-Reviewed Original Research
2017
Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143
Omuro A, Vlahovic G, Lim M, Sahebjam S, Baehring J, Cloughesy T, Voloschin A, Ramkissoon SH, Ligon KL, Latek R, Zwirtes R, Strauss L, Paliwal P, Harbison CT, Reardon DA, Sampson JH. Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143. Neuro-Oncology 2017, 20: 674-686. PMID: 29106665, PMCID: PMC5892140, DOI: 10.1093/neuonc/nox208.Peer-Reviewed Original ResearchConceptsAdverse eventsRecurrent glioblastomaCommon treatment-related adverse eventsTreatment-related adverse eventsDeath ligand 1 (PD-L1) expressionEffects of nivolumabExploratory efficacy outcomesSafety/tolerabilityFindings merit further investigationLigand 1 expressionCheckMate 143Ipilimumab doseNivolumab monotherapyStable diseaseAlternative regimenEfficacy outcomesRadiographic progressionMost patientsPartial responseNivolumabIpilimumabMerit further investigationPatientsI cohortFurther evaluationNivolumab combined with hypofractionated stereotactic irradiation (HFSRT) for patients with recurrent high grade gliomas: A phase I trial (NCT02829931).
Sahebjam S, Forsyth P, Arrington J, Tran N, Jaglal M, Mokhtari S, Long W, Macaulay R, Wicklund M, Drury-Sibiga A, Gatewood T, Robinson T, Raval R, Yu M. Nivolumab combined with hypofractionated stereotactic irradiation (HFSRT) for patients with recurrent high grade gliomas: A phase I trial (NCT02829931). Journal Of Clinical Oncology 2017, 35: tps2084-tps2084. DOI: 10.1200/jco.2017.35.15_suppl.tps2084.Peer-Reviewed Original ResearchHigh-grade gliomasPhase I trialGrade gliomasI trialPD-1PD-L1Grade IIIAnti-PD-1/PD-L1 blockadePD-1/PD-L1 blockadeRecurrent high-grade gliomaOngoing phase I trialDose-expansion cohortsPD-L1 blockadePrior radiation therapyTolerability of nivolumabGroup of patientsImmune checkpoint pathwaysLimited treatment optionsPreliminary antitumor activityOrthotopic murine modelLong-term survivalPrimary study objectiveIgG4 monoclonal antibodyNivolumab monotherapySafety cohortOA03.01 First-Line Nivolumab Monotherapy and Nivolumab plus Ipilimumab in Patients with Advanced NSCLC: Long-Term Outcomes from CheckMate 012
Gettinger S, Rizvi N, Chow L, Borghaei H, Brahmer J, Shepherd F, Ready N, Gerber D, Antonia S, Goldman J, Juergens R, Geese W, Young T, Li X, Hellmann M. OA03.01 First-Line Nivolumab Monotherapy and Nivolumab plus Ipilimumab in Patients with Advanced NSCLC: Long-Term Outcomes from CheckMate 012. Journal Of Thoracic Oncology 2017, 12: s250-s251. DOI: 10.1016/j.jtho.2016.11.238.Peer-Reviewed Original Research
2016
Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma
Weber JS, Hodi FS, Wolchok JD, Topalian SL, Schadendorf D, Larkin J, Sznol M, Long GV, Li H, Waxman IM, Jiang J, Robert C. Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. Journal Of Clinical Oncology 2016, 35: jco.2015.66.138. PMID: 28068177, DOI: 10.1200/jco.2015.66.1389.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsSelect adverse eventsObjective response rateImmune-modulating agentsTreatment-related select adverse eventsAdverse eventsNivolumab monotherapyAdvanced melanomaSafety profileGrade 3Grade treatment-related adverse eventsProgression-free survival benefitHigher objective response rateRenal adverse eventsPhase III trialsDrug-related deathsNumber of dosesIII trialsSurvival benefitMedian timePooled analysisSafety guidelinesRetrospective analysisSafety dataPatientsEfficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis
D'Angelo SP, Larkin J, Sosman JA, Lebbé C, Brady B, Neyns B, Schmidt H, Hassel JC, Hodi FS, Lorigan P, Savage KJ, Miller WH, Mohr P, Marquez-Rodas I, Charles J, Kaatz M, Sznol M, Weber JS, Shoushtari AN, Ruisi M, Jiang J, Wolchok JD. Efficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis. Journal Of Clinical Oncology 2016, 35: 226-235. PMID: 28056206, PMCID: PMC5559888, DOI: 10.1200/jco.2016.67.9258.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalObjective response rateProgression-free survivalMucosal melanomaCutaneous melanomaNivolumab monotherapyAnti-programmed death-1 therapyResponse rateTreatment-related adverse eventsSafety of nivolumabPhase III trialsRare melanoma subtypeNivolumab AloneAdverse eventsIII trialsSafety profileAggressive malignancyCombination therapyConventional therapyPooled analysisPoor responseClinical studiesGrade 3IpilimumabMelanoma subtypesNivolumab 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 drugNivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer
Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD. Nivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 2980-2987. PMID: 27354485, PMCID: PMC5569692, DOI: 10.1200/jco.2016.66.9929.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-ligand 1 (PD-L1) expressionAdverse eventsOverall survivalNivolumab monotherapyAdvanced NSCLCLung cancerGrade 3Death-1 immune checkpoint inhibitor antibodyAdvanced non-small cell lung cancerGrade treatment-related adverse eventsNon-small cell lung cancerImmune checkpoint inhibitor antibodyProgression-free survival ratesCheckpoint inhibitor antibodyExploratory end pointsFirst tumor assessmentFirst-line monotherapyOngoing complete responseTolerable safety profileMedian overall survivalGrade 3 rashOnly grade 3Cell lung cancerSafety and activity of nivolumab (nivo) monotherapy and nivo in combination with ipilimumab (ipi) in recurrent glioblastoma (GBM): Updated results from checkmate-143.
Reardon D, Sampson J, Sahebjam S, Lim M, Baehring J, Vlahovic G, Cloughesy T, Strauss L, Latek R, Paliwal P, Harbison C, Voloschin A, Omuro A. Safety and activity of nivolumab (nivo) monotherapy and nivo in combination with ipilimumab (ipi) in recurrent glioblastoma (GBM): Updated results from checkmate-143. Journal Of Clinical Oncology 2016, 34: 2014-2014. DOI: 10.1200/jco.2016.34.15_suppl.2014.Peer-Reviewed Original ResearchEfficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study.
Sharma P, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai R, Ott P, De Braud F, Morse M, Le D, Jaeger D, Chan E, Harbison C, Lin C, Tschaika M, Azrilevich A, Rosenberg J. Efficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study. Journal Of Clinical Oncology 2016, 34: 4501-4501. DOI: 10.1200/jco.2016.34.15_suppl.4501.Peer-Reviewed Original Research
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