2022
FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy
Choueiri T, Kluger H, George S, Tykodi S, Kuzel T, Perets R, Nair S, Procopio G, Carducci M, Castonguay V, Folefac E, Lee C, Hotte S, Miller W, Saggi S, Lee C, Desilva H, Bhagavatheeswaran P, Motzer R, Escudier B. FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy. Journal For ImmunoTherapy Of Cancer 2022, 10: e005780. PMID: 36328377, PMCID: PMC9639138, DOI: 10.1136/jitc-2022-005780.Peer-Reviewed Original ResearchConceptsAdvanced renal cell carcinomaObjective response rateDuration of responseIO therapyImmuno-oncology therapiesRenal cell carcinomaOverall survivalCell carcinomaAnti-PD-1/PD-L1 therapyImmune-mediated adverse eventsMedian DORProgression-free survival ratesTreatment-related deathsManageable safety profileMedian overall survivalPD-L1 therapyDurable clinical benefitKarnofsky performance statusPrimary outcome measureHigh unmet needExploratory endpointsIpilimumab armPFS ratesStable diseaseAdverse events
2020
FRACTION-RCC: Innovative, high-throughput assessment of nivolumab + ipilimumab for treatment-refractory advanced renal cell carcinoma (aRCC).
Choueiri T, Kluger H, George S, Tykodi S, Kuzel T, Perets R, Nair S, Procopio G, Carducci M, Castonguay V, Folefac E, Lee C, Hotte S, Miller W, Saggi S, Gold D, Motzer R, Escudier B. FRACTION-RCC: Innovative, high-throughput assessment of nivolumab + ipilimumab for treatment-refractory advanced renal cell carcinoma (aRCC). Journal Of Clinical Oncology 2020, 38: 5007-5007. DOI: 10.1200/jco.2020.38.15_suppl.5007.Peer-Reviewed Original ResearchAdvanced renal cell carcinomaDuration of responseTreatment-related adverse eventsAdverse eventsPartial responsePrior linesGrade treatment-related adverse eventsImmune-mediated adverse eventsProgression-free survival probabilityDurable partial responseTreatment-related deathsCheckpoint inhibitor therapyObjective response rateCheckpoint inhibitor treatmentRenal cell carcinomaCombination nivolumabInvestigational combinationPrior TKICheckpoint inhibitorsPrimary endpointWeek 24Complete responseInhibitor therapyTKI therapyPrior progressionMelanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy
Margolin K, Davies M, Kluger H, Tawbi H. Melanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy. 2020, 1421-1454. DOI: 10.1007/978-3-030-05070-2_65.Peer-Reviewed Original ResearchMelanoma brain metastasesCentral nervous systemSystemic therapyClinical benefitMainstay of therapyUnique patient populationDuration of responseHigh response rateFuture drug developmentMelanoma metastaticBrain metastasesDevastating complicationDurable responsesImmune checkpointsImmune therapyPatient populationMetastatic melanomaEffective modalityStereotactic radiosurgeryNervous systemResponse rateTherapyMultidisciplinary approachDrug developmentMelanoma
2019
Melanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy
Margolin K, Davies M, Kluger H, Tawbi H. Melanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy. 2019, 1-34. DOI: 10.1007/978-3-319-46029-1_65-1.Peer-Reviewed Original ResearchMelanoma brain metastasesCentral nervous systemSystemic therapyClinical benefitMainstay of therapyUnique patient populationDuration of responseHigh response rateFuture drug developmentMelanoma metastaticBrain metastasesDevastating complicationDurable responsesImmune checkpointsImmune therapyPatient populationMetastatic melanomaEffective modalityStereotactic radiosurgeryNervous systemResponse rateTherapyMultidisciplinary approachDrug developmentMelanoma
2015
Survival, Durable Response, and Long-Term Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab
McDermott DF, Drake CG, Sznol M, Choueiri TK, Powderly JD, Smith DC, Brahmer JR, Carvajal RD, Hammers HJ, Puzanov I, Hodi FS, Kluger HM, Topalian SL, Pardoll DM, Wigginton JM, Kollia GD, Gupta A, McDonald D, Sankar V, Sosman JA, Atkins MB. Survival, Durable Response, and Long-Term Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab. Journal Of Clinical Oncology 2015, 33: 2013-2020. PMID: 25800770, PMCID: PMC4517051, DOI: 10.1200/jco.2014.58.1041.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Renal CellCohort StudiesDisease-Free SurvivalDose-Response Relationship, DrugFemaleHumansKidney NeoplasmsMaleMaximum Tolerated DoseMiddle AgedNivolumabPatient SafetyProgrammed Cell Death 1 ReceptorTime FactorsTreatment OutcomeConceptsAdvanced renal cell carcinomaRenal cell carcinomaLong-term safetyOverall survivalDurable responsesTreatment-refractory solid tumorsTreatment-related adverse eventsOngoing randomized clinical trialsImpact of nivolumabMedian overall survivalMedian response durationPortion of patientsDuration of responseRandomized clinical trialsDrug discontinuationIntravenous nivolumabStable diseaseExpansion cohortTreatment discontinuationAdverse eventsObjective responseAdditional patientsAntibody nivolumabCell surface moleculesCell carcinoma
2009
A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate (ADC) targeting glycoprotein NMB (GPNMB) in patients (pts) with advanced melanoma
Hwu P, Sznol M, Pavlick A, Kluger H, Kim K, Boasberg P, Sanders D, Simantov R, Crowley E, Hamid O. A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate (ADC) targeting glycoprotein NMB (GPNMB) in patients (pts) with advanced melanoma. Journal Of Clinical Oncology 2009, 27: 9032-9032. DOI: 10.1200/jco.2009.27.15_suppl.9032.Peer-Reviewed Original ResearchProgression-free survivalCR011-vcMMAEPartial responseAntibody-drug conjugatesGlycoprotein NMBMonomethylauristatin EAdvanced melanomaPhase I/II studyCommon grade 3/4 AEsMedian progression-free survivalLonger progression-free survivalUnconfirmed partial responseUnresectable stage IIIStage IV melanomaDuration of responseOverall responseHuman monoclonal antibodyPhase II dataCytotoxic regimenEligible ptsCommon AEsIntolerable toxicityPrimary endpointSecondary endpointsFree survival