2017
Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator’s Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial
Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator’s Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. Journal Of Clinical Oncology 2017, 36: jco.2016.71.802. PMID: 28671856, PMCID: PMC6804912, DOI: 10.1200/jco.2016.71.8023.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, IntravenousAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDacarbazineDisease ProgressionDrug Administration ScheduleFemaleHumansMaleMelanomaMiddle AgedNivolumabPaclitaxelProgression-Free SurvivalSkin NeoplasmsTime FactorsYoung AdultConceptsInvestigator-choice chemotherapyAdvanced melanomaAnti-programmed death-1 (PD-1) agentsOpen-label phase III trialMedian progression-free survivalResults Two hundred seventyTreatment-related adverse eventsIpilimumab-refractory patientsNivolumab-treated patientsPhase III trialsProgression-free survivalProportion of patientsPoor prognostic factorOverall response rateLactate dehydrogenase levelsSurvival end pointsConclusion NivolumabMedian OSNivolumab groupBrain metastasesChemotherapy regimensUnacceptable toxicityAdverse eventsDurable responsesIII trials
2015
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. New England Journal Of Medicine 2015, 373: 23-34. PMID: 26027431, PMCID: PMC5698905, DOI: 10.1056/nejmoa1504030.Peer-Reviewed Original ResearchConceptsProgression-free survivalMedian progression-free survivalIpilimumab groupMetastatic melanomaNivolumab groupUntreated patientsPD-L1Negative tumorsTreatment-related adverse eventsLonger progression-free survivalUnresectable stage IIICoprimary end pointsCTLA-4 blockadePhase 3 studyPD-1 ligandsCombined NivolumabAdverse eventsOverall survivalPD-1Combination therapyUntreated melanomaIpilimumabNivolumabGrade 3Stage III