2025
Metabolic determinants of exceptional response to immune checkpoint inhibition in renal cell carcinoma.
Saliby R, Labaki C, Jammihal T, Soulati H, Gallegos J, Peris A, McCurry D, Shah V, Poduval D, El Zarif T, El Ahmar N, Nabil Laimon Y, Bagheri Sheshdeh A, Eid M, Krajewski K, Signoretti S, Van Allen E, Shukla S, Choueiri T, Braun D. Metabolic determinants of exceptional response to immune checkpoint inhibition in renal cell carcinoma. Journal Of Clinical Oncology 2025, 43: 571-571. DOI: 10.1200/jco.2025.43.5_suppl.571.Peer-Reviewed Original ResearchProgression-free survivalImmune checkpoint inhibitorsRenal cell carcinomaComplete responsePartial responseProgressive diseaseWhole-exome sequencingMetabolic gene signatureOverall survivalVEGF inhibitorsCell carcinomaGene Set Enrichment AnalysisER patientsSignature scorePatients treated with immune checkpoint inhibitorsResponse to immune checkpoint inhibitionResponse to ICIExceptional responseAdvanced clear cell renal cell carcinomaProgression-free survival predictorsProlonged progression-free survivalMetastatic renal cell carcinomaMultivariate Cox proportional hazards analysisGene signaturePhase III clinical trialsAssociation between PD-1 expression on tumor-infiltrating regulatory T cells and resistance to first-line nivolumab in advanced clear cell renal cell carcinoma: Insights from the HCRN GU16-260 clinical trial.
Mohanna R, Simsek B, El Ahmar N, Jegede O, Matar S, Paul M, Nabil Laimon Y, Roberti De Oliveira G, Delcea A, Choueiri T, Braun D, Haas N, Hammers H, Bilen M, Stein M, Sosman J, Wu C, McDermott D, Atkins M, Signoretti S. Association between PD-1 expression on tumor-infiltrating regulatory T cells and resistance to first-line nivolumab in advanced clear cell renal cell carcinoma: Insights from the HCRN GU16-260 clinical trial. Journal Of Clinical Oncology 2025, 43: 590-590. DOI: 10.1200/jco.2025.43.5_suppl.590.Peer-Reviewed Original ResearchAdvanced clear cell renal cell carcinomaClear cell renal cell carcinomaProgression-free survivalPD-1 expressionTumor-infiltrating TregsCell renal cell carcinomaRegulatory T cellsPD-1Renal cell carcinomaClinical trialsCell carcinomaT cellsEfficacy of PD-1 blockadeInhibition of PD-1 signalingLevel of PD-1 expressionShorter median progression-free survivalTumor-infiltrating regulatory T cellsAssociated with progression-free survivalMedian progression-free survivalPercentage of PD-1First-line nivolumabFirst-line settingPD-1 blockadePD-1 signalingLog-rank test
2024
Molecular analysis of the HCRN GU16-260-Cohort A phase II study of first-line (1L) nivolumab (nivo) and salvage nivo + ipilimumab (ipi) in patients (pts) with advanced clear cell renal cell carcinoma (accRCC).
Zaemes J, Hugaboom M, Shah V, Haas N, McDermott D, Jegede O, Bilen M, Stein M, Sosman J, Alter R, Plimack E, Hurwitz M, Wu C, Einstein D, Hammers H, Signoretti S, West D, Denize T, Atkins M, Braun D. Molecular analysis of the HCRN GU16-260-Cohort A phase II study of first-line (1L) nivolumab (nivo) and salvage nivo + ipilimumab (ipi) in patients (pts) with advanced clear cell renal cell carcinoma (accRCC). Journal Of Clinical Oncology 2024, 42: 4546-4546. DOI: 10.1200/jco.2024.42.16_suppl.4546.Peer-Reviewed Original ResearchObjective response rateImmune checkpoint blockadeProgression-free survivalProgressive diseaseAnti-VEGFOverall survivalAssociated with higher progression-free survivalTumor samplesAdvanced clear cell renal cell carcinomaCombined immune checkpoint blockadeHigher progression-free survivalIncreased PFSImmune checkpoint blockade therapyShorter progression-free survivalClear cell renal cell carcinomaAnti-VEGF therapyCell renal cell carcinomaWeeks of therapyRenal cell carcinomaBiomarkers of efficacyFFPE tumor samplesNIVO monotherapyCheckpoint blockadeDecreased OSProspective trialsCD70-Targeted Allogeneic CAR T-Cell Therapy for Advanced Clear Cell Renal Cell Carcinoma
Pal S, Tran B, Haanen J, Hurwitz M, Sacher A, Tannir N, Budde L, Harrison S, Klobuch S, Patel S, Meza L, Dequeant M, Ma A, He Q, Williams L, Keegan A, Gurary E, Dar H, Karnik S, Guo C, Heath H, Yuen R, Morrow P, Agarwal N, Srour S. CD70-Targeted Allogeneic CAR T-Cell Therapy for Advanced Clear Cell Renal Cell Carcinoma. Cancer Discovery 2024, 14: of1-of14. PMID: 38583184, PMCID: PMC11215406, DOI: 10.1158/2159-8290.cd-24-0102.Peer-Reviewed Original ResearchClear cell renal cell carcinomaChimeric antigen receptorCAR-T cellsT-cell therapyCell renal cell carcinomaRenal cell carcinomaT cellsCell carcinomaSolid tumorsAllogeneic CAR-T cell therapyChimeric antigen receptor T cellsAdvanced clear cell renal cell carcinomaAllogeneic CAR-T cellsClinical trialsCAR-T cell productsCAR-T cell therapyTreatment of solid tumorsFirst-in-human clinical trialCAR-T constructsDose-limiting toxicityT cell productionNovel treatment optionsTreatment of clear cell renal cell carcinomaHematologic malignanciesAntigen receptorTumor-infiltrating CD163-positive macrophages and clinical outcomes to first-line nivolumab therapy in patients with advanced clear cell renal cell carcinoma (ccRCC) enrolled in the HCRN GU16-260 trial.
El Ahmar N, Matar S, Jegede O, Nabil Laimon Y, Savla V, Bagheri Sheshdeh A, Denize T, Mohanna R, Choueiri T, Catalano P, Braun D, Haas N, Hammers H, Bilen M, Stein M, Sosman J, Wu C, McDermott D, Atkins M, Signoretti S. Tumor-infiltrating CD163-positive macrophages and clinical outcomes to first-line nivolumab therapy in patients with advanced clear cell renal cell carcinoma (ccRCC) enrolled in the HCRN GU16-260 trial. Journal Of Clinical Oncology 2024, 42: 448-448. DOI: 10.1200/jco.2024.42.4_suppl.448.Peer-Reviewed Original ResearchClear cell renal cell carcinomaProgression-free survivalCD163-positive macrophagesTumor areaNivolumab therapyDensity of CD163-positive cellsCD8+ T cell infiltrationAssociated with progression-free survivalResponse to immune checkpoint inhibitorsAdvanced clear cell renal cell carcinomaAnti-PD-1 therapyTumor-infiltrating myeloid cellsProgression-free survival endpointAssociated with poor outcomesFirst-line nivolumabImmune checkpoint inhibitorsMyeloid cell infiltrationT cell infiltrationCell renal cell carcinomaRenal cell carcinomaPrimary tumor tissuesCD163-positive cellsCheckpoint inhibitorsCox proportional hazardsCell carcinoma
2023
A Pooled Analysis of 3 Phase II Trials of Salvage Nivolumab/Ipilimumab After Nivolumab in Renal Cell Carcinoma
McKay R, Leucht K, Xie W, Jegede O, Braun D, Atkins M, Grimm M, Choueiri T. A Pooled Analysis of 3 Phase II Trials of Salvage Nivolumab/Ipilimumab After Nivolumab in Renal Cell Carcinoma. The Oncologist 2023, 29: 324-331. PMID: 37950901, PMCID: PMC10994246, DOI: 10.1093/oncolo/oyad298.Peer-Reviewed Original ResearchObjective response rateClear cell renal cell carcinomaRenal cell carcinomaProgression-free survivalCell renal cell carcinomaAdvanced clear cell renal cell carcinomaOverall survivalCell carcinomaPooled analysisSix-month progression-free survivalBest objective response rateActivity of nivolumabInitiation of nivolumabNivolumab/ipilimumabPoor-risk diseasePhase II trialEligible patientsII trialObjective responsePrior immunotherapyImproved survivalRisk diseaseClinical trialsIpilimumabNivolumabTreatment-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
558 CTX130 allogeneic CRISPR-Cas9–engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: Results from the phase 1 COBALT-RCC study
Pal S, Tran B, Haanen J, Hurwitz M, Sacher A, Agarwal N, Tannir N, Budde E, Harrison S, Klobuch S, Patel S, Dequeant M, Karsten V, Cohen K, Gurary E, Dar H, Ma A, Sharma A, Srour S. 558 CTX130 allogeneic CRISPR-Cas9–engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: Results from the phase 1 COBALT-RCC study. 2022, a584-a584. DOI: 10.1136/jitc-2022-sitc2022.0558.Peer-Reviewed Original ResearchAdvanced clear cell renal cell carcinomaClear cell renal cell carcinomaChimeric antigen receptorCell renal cell carcinomaRenal cell carcinomaCell carcinomaT cellsAntigen receptorCarcinomaBempegaldesleukin plus nivolumab in first-line renal cell carcinoma: results from the PIVOT-02 study
Tannir NM, Cho DC, Diab A, Sznol M, Bilen MA, Balar AV, Grignani G, Puente E, Tang L, Chien D, Hoch U, Choudhury A, Yu D, Currie SL, Tagliaferri MA, Zalevsky J, Siefker-Radtke AO, Hurwitz ME. Bempegaldesleukin plus nivolumab in first-line renal cell carcinoma: results from the PIVOT-02 study. Journal For ImmunoTherapy Of Cancer 2022, 10: e004419. PMID: 35444058, PMCID: PMC9021810, DOI: 10.1136/jitc-2021-004419.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsRenal cell carcinomaProgression-free survivalAdvanced clear cell renal cell carcinomaClear cell renal cell carcinomaFirst-line therapyOverall survivalCell carcinomaGrade 3/4 treatment-related adverse eventsSingle-arm phase 1/2 studyMedian progression-free survivalMedian overall survivalObjective response ratePhase 1/2 studyCent of patientsPreliminary antitumor activitySingle-arm designAdverse eventsComplete responseBaseline biomarkersTreatment optionsExploratory biomarkersRCC cohortBempegaldesleukinNivolumab
2020
Interplay of somatic alterations and immune infiltration modulates response to PD-1 blockade in advanced clear cell renal cell carcinoma
Braun DA, Hou Y, Bakouny Z, Ficial M, Sant’ Angelo M, Forman J, Ross-Macdonald P, Berger AC, Jegede OA, Elagina L, Steinharter J, Sun M, Wind-Rotolo M, Pignon JC, Cherniack AD, Lichtenstein L, Neuberg D, Catalano P, Freeman GJ, Sharpe AH, McDermott DF, Van Allen EM, Signoretti S, Wu CJ, Shukla SA, Choueiri TK. Interplay of somatic alterations and immune infiltration modulates response to PD-1 blockade in advanced clear cell renal cell carcinoma. Nature Medicine 2020, 26: 909-918. PMID: 32472114, PMCID: PMC7499153, DOI: 10.1038/s41591-020-0839-y.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntigen PresentationAntineoplastic Agents, ImmunologicalCarcinoma, Renal CellCD8-Positive T-LymphocytesChromosome DeletionChromosomes, Human, Pair 6Chromosomes, Human, Pair 9Class I Phosphatidylinositol 3-KinasesDNA-Binding ProteinsExome SequencingFemaleFluorescent Antibody TechniqueGene DeletionGenomicsHistocompatibility Antigens Class IIHistone DemethylasesHistone-Lysine N-MethyltransferaseHumansKidney NeoplasmsLymphocytes, Tumor-InfiltratingMaleMiddle AgedMutationNivolumabPrognosisProteasome Endopeptidase ComplexPTEN PhosphohydrolaseSequence Analysis, RNATOR Serine-Threonine KinasesTranscription FactorsTuberous Sclerosis Complex 1 ProteinTumor Suppressor ProteinsUbiquitin ThiolesteraseVon Hippel-Lindau Tumor Suppressor ProteinConceptsAdvanced clear cell renal cell carcinomaClear cell renal cell carcinomaPD-1 blockadeCell renal cell carcinomaRenal cell carcinomaCell carcinomaDegree of CD8Numerous chromosomal alterationsProspective clinical trialsSomatic alterationsInfiltrated tumorsClinical responseCell infiltrationTherapeutic responseClinical trialsTherapeutic efficacyBlockadeCcRCC tumorsTumorsPBRM1 mutationsModulates responseCD8Chromosomal alterationsImmunofluorescence analysisCarcinoma
2019
DNA Damage Response Pathway Alteration in Locally Advanced Clear-Cell Renal-Cell Carcinoma Is Associated With a Poor Outcome
Na J, Nagaya N, Rha K, Han W, Kim I. DNA Damage Response Pathway Alteration in Locally Advanced Clear-Cell Renal-Cell Carcinoma Is Associated With a Poor Outcome. Clinical Genitourinary Cancer 2019, 17: 299-305.e1. PMID: 31204211, DOI: 10.1016/j.clgc.2019.05.004.Peer-Reviewed Original ResearchConceptsClear cell renal cell carcinomaDisease-free survivalAdvanced clear cell renal cell carcinomaDDR pathway alterationPathway alterationsLocalized Clear Cell Renal Cell CarcinomaDecreased disease-free survivalTCGA databaseShorter disease-free survivalCopy number alterationsTherapeutic agentsCox regression analysisT3-4 diseaseClear-Cell RenalRenal cell carcinomaDDR pathwaysPresence of mutationsT3a diseaseNeoadjuvant therapyOverall survivalPoor outcomeCell carcinomaCommon subtypeDisease progressionKidney cancer
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