2019
1375TiP Pembrolizumab (pembro) plus lenvatinib (len) for first-line treatment of patients (pts) with advanced melanoma: Phase III LEAP-003 study
Eggermont A, Carlino M, Hauschild A, Ascierto P, Arance A, Daud A, O’Day S, Taylor M, Smith A, Rodgers A, Moreno B, Diede S, Kluger H. 1375TiP Pembrolizumab (pembro) plus lenvatinib (len) for first-line treatment of patients (pts) with advanced melanoma: Phase III LEAP-003 study. Annals Of Oncology 2019, 30: v561. DOI: 10.1093/annonc/mdz255.063.Peer-Reviewed Original ResearchBlinded independent central reviewPD-1 inhibitorsAdvanced melanomaSanofi GenzymeSubsidiary of MerckArray BioPharmaDohme Corp.Pierre FabreRoche-GenentechEnd pointMerck SharpBaseline tumor samplesNCI CTCAE v4.0Performance status 0/1Antitumor activityPrimary end pointSecondary end pointsFirst-line standardFirst-line treatmentUntreated stage IIIIndependent central reviewMurine tumor modelsPDGF receptor αEligible ptsQd po
2013
Activity of cabozantinib in metastatic uveal melanoma: Updated results from a phase II randomized discontinuation trial (RDT).
Daud A, Kluger H, Edelman G, Gordon M, Schimmoller F, Weitzman A, Samuel T, Moussa A, Flaherty K, Shapiro G. Activity of cabozantinib in metastatic uveal melanoma: Updated results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2013, 31: 9094-9094. DOI: 10.1200/jco.2013.31.15_suppl.9094.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalMetastatic uveal melanomaUveal melanomaMelanoma cohortRandomized phase 2 studyGNA11 mutationsActivity of cabozantinibGrade 3/4 AEsSafety of cabozantinibSubstantial tumor burdenObjective tumor regressionPhase 2 studyStudy days 1Long-term followupTumor mutation statusGNAQ/GNA11 mutationsUpregulation of METEligible ptsAbdominal painMeasurable diseaseMedian PFSPrior regimensTerm FollowupMedian age
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