2023
Outcomes With Combination Pembrolizumab and Axitinib in Second and Further Line Treatment of Metastatic Renal Cell Carcinoma
Dizman N, Austin M, Considine B, Jessel S, Schoenfeld D, Merl M, Hurwitz M, Sznol M, Kluger H. Outcomes With Combination Pembrolizumab and Axitinib in Second and Further Line Treatment of Metastatic Renal Cell Carcinoma. Clinical Genitourinary Cancer 2023, 21: 221-229. PMID: 36681606, DOI: 10.1016/j.clgc.2023.01.002.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaPembrolizumab/axitinibObjective response rateProgression-free survivalImmune checkpoint inhibitorsMedian progression-free survivalAdverse eventsRenal cell carcinomaCell carcinomaClear cell metastatic renal cell carcinomaVascular endothelial growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsCombination immune checkpoint inhibitorsGrade 5 adverse eventsPrior immune checkpoint inhibitorsSuperior progression-free survivalReceptor tyrosine kinase inhibitorsYale-New Haven HospitalFurther-line treatmentNivolumab/ipilimumabRECIST 1.1 criteriaResponse-evaluable patientsDisease control rateSecond-line therapyFirst-line treatment
2021
Three-year survival, correlates and salvage therapies in patients receiving first-line pembrolizumab for advanced Merkel cell carcinoma
Nghiem P, Bhatia S, Lipson EJ, Sharfman WH, Kudchadkar RR, Brohl AS, Friedlander PA, Daud A, Kluger HM, Reddy SA, Boulmay BC, Riker A, Burgess MA, Hanks BA, Olencki T, Kendra K, Church C, Akaike T, Ramchurren N, Shinohara MM, Salim B, Taube JM, Jensen E, Kalabis M, Fling SP, Moreno B, Sharon E, Cheever MA, Topalian SL. Three-year survival, correlates and salvage therapies in patients receiving first-line pembrolizumab for advanced Merkel cell carcinoma. Journal For ImmunoTherapy Of Cancer 2021, 9: e002478. PMID: 33879601, PMCID: PMC8061836, DOI: 10.1136/jitc-2021-002478.Peer-Reviewed Original ResearchConceptsProgression-free survivalMerkel cell carcinomaSalvage therapyStable diseaseCell carcinomaBaseline Eastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group performance statusAnti-programmed death-1 therapyCell death-1 pathway inhibitorsDeath-1 pathway inhibitorsDurable progression-free survivalFirst-line pembrolizumab therapyMedian progression-free survivalMulticenter phase II trialRefractory Merkel cell carcinomaTumor progressionAdvanced Merkel cell carcinomaMedian response durationFirst-line pembrolizumabPhase II trialProportion of patientsInitial disease progressionThree-year survivalDurable tumor regressionOverall response rate
2018
Results of a Phase II Placebo-controlled Randomized Discontinuation Trial of Cabozantinib in Patients with Non–small-cell Lung Carcinoma
Hellerstedt BA, Vogelzang NJ, Kluger HM, Yasenchak CA, Aftab DT, Ramies DA, Gordon MS, Lara P. Results of a Phase II Placebo-controlled Randomized Discontinuation Trial of Cabozantinib in Patients with Non–small-cell Lung Carcinoma. Clinical Lung Cancer 2018, 20: 74-81.e1. PMID: 30528315, DOI: 10.1016/j.cllc.2018.10.006.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalMedian progression-free survivalCell lung carcinomaWeek 12Adverse eventsDiscontinuation trialLung carcinomaTreatment-related grade 5 adverse eventsCommon grade 3/4 adverse eventsBioavailable tyrosine kinase inhibitorGrade 3/4 adverse eventsGrade 5 adverse eventsOverall disease control rateSolid Tumors version 1.0Epidermal growth factor receptor (EGFR) mutationsOpen-label leadPhase II PlaceboRandomized discontinuation trialDisease control ratePalmar-plantar erythrodysesthesiaResponse Evaluation CriteriaGrowth factor receptor 2Vascular endothelial growth factor receptor 2Endothelial growth factor receptor 2
2012
Activity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT).
Gordon M, Kluger H, Shapiro G, Kurzrock R, Edelman G, Samuel T, Moussa A, Ramies D, Laird A, Schimmoller F, Shen X, Daud A. Activity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 8531-8531. DOI: 10.1200/jco.2012.30.15_suppl.8531.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalObjective tumor regressionTumor regressionPost-baseline tumour assessmentMedian age 66 yearsActivity of cabozantinibGrade 3/4 AEsGrade 5 AEsMedian prior linesOpen-label leadAge 66 yearsStudy days 1BRAF mutation statusMeasurable diseaseDiverticular perforationEligible patientsPrimary endpointFree survivalPain reliefPrior linesMonth 6VEGFR-TKIDiscontinuation trialSafety profile
2010
A phase 2 trial of dasatinib in advanced melanoma
Kluger HM, Dudek AZ, McCann C, Ritacco J, Southard N, Jilaveanu LB, Molinaro A, Sznol M. A phase 2 trial of dasatinib in advanced melanoma. Cancer 2010, 117: 2202-2208. PMID: 21523734, PMCID: PMC3116034, DOI: 10.1002/cncr.25766.Peer-Reviewed Original ResearchConceptsProgression-free survivalC-kit mutationsPhase 2 trialResponse ratePartial responseMedian progression-free survivalMelanoma cell proliferationDaily dasatinibMucosal primaryPFS ratesStarting dosageCommon toxicitiesUnresectable melanomaAdvanced melanomaPleural effusionMelanoma patientsPredictive biomarkersMinor responseCombination trialsTumor assessmentDose reductionPatientsPrespecified endpointsDasatinibMelanoma
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