2015
Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial
Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, Hoeller C, Khushalani NI, Miller WH, Lao CD, Linette GP, Thomas L, Lorigan P, Grossmann KF, Hassel JC, Maio M, Sznol M, Ascierto PA, Mohr P, Chmielowski B, Bryce A, Svane IM, Grob JJ, Krackhardt AM, Horak C, Lambert A, Yang AS, Larkin J. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. The Lancet Oncology 2015, 16: 375-384. PMID: 25795410, DOI: 10.1016/s1470-2045(15)70076-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCTLA-4 AntigenDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsFemaleHumansIpilimumabMaleMelanomaMiddle AgedNeoplasm StagingNivolumabPaclitaxelProto-Oncogene Proteins B-rafConceptsPhase 3 trialObjective responseAdvanced melanomaBRAF inhibitorsPrimary endpointAdverse eventsGrade 3Human IgG4 PD-1 immune checkpoint inhibitor antibodyDrug-related serious adverse eventsICC groupImmune checkpoint inhibitor antibodyCheckpoint inhibitor antibodyDurable objective responsesLater-line treatmentNivolumab-treated patientsSafety of nivolumabTreatment-related deathsUnacceptable toxic effectsSerious adverse eventsProportion of patientsFirst interim analysisNew treatment optionsBest overall responseDose of treatmentHigh unmet need
2014
Combined BRAF (Dabrafenib) and MEK Inhibition (Trametinib) in Patients With BRAFV600-Mutant Melanoma Experiencing Progression With Single-Agent BRAF Inhibitor
Johnson DB, Flaherty KT, Weber JS, Infante JR, Kim KB, Kefford RF, Hamid O, Schuchter L, Cebon J, Sharfman WH, McWilliams RR, Sznol M, Lawrence DP, Gibney GT, Burris HA, Falchook GS, Algazi A, Lewis K, Long GV, Patel K, Ibrahim N, Sun P, Little S, Cunningham E, Sosman JA, Daud A, Gonzalez R. Combined BRAF (Dabrafenib) and MEK Inhibition (Trametinib) in Patients With BRAFV600-Mutant Melanoma Experiencing Progression With Single-Agent BRAF Inhibitor. Journal Of Clinical Oncology 2014, 32: 3697-3704. PMID: 25287827, PMCID: PMC4226803, DOI: 10.1200/jco.2014.57.3535.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDisease ProgressionDisease-Free SurvivalFemaleHumansImidazolesMaleMelanomaMiddle AgedMitogen-Activated Protein Kinase KinasesMutationOximesProtein Kinase InhibitorsProto-Oncogene Proteins B-rafPyridonesPyrimidinonesConceptsObjective response rateProgression-free survivalMedian progression-free survivalEfficacy of dabrafenibBRAF inhibitor treatmentBRAF inhibitorsOpen-label phase I/II studyInhibitor treatmentPhase I/II studySingle-agent BRAF inhibitorsMEK inhibitionBRAF inhibitor-resistant melanomaBRAF inhibitor monotherapyMedian overall survivalModest clinical efficacyBRAF inhibitor therapyEarly clinical studiesDabrafenib monotherapyInitial therapyStable diseaseII studyInhibitor monotherapyOverall survivalInhibitor therapyStudy enrollment