2020
Safety and efficacy of combination nivolumab plus ipilimumab in patients with advanced melanoma: results from a North American expanded access program (CheckMate 218)
Hodi FS, Chapman PB, Sznol M, Lao CD, Gonzalez R, Smylie M, Daniels GA, Thompson JA, Kudchadkar R, Sharfman W, Atkins M, Spigel DR, Pavlick A, Monzon J, Kim KB, Ernst S, Khushalani NI, van Dijck W, Lobo M, Hogg D. Safety and efficacy of combination nivolumab plus ipilimumab in patients with advanced melanoma: results from a North American expanded access program (CheckMate 218). Melanoma Research 2020, 31: 67-75. PMID: 33234846, PMCID: PMC7757740, DOI: 10.1097/cmr.0000000000000708.Peer-Reviewed Original ResearchConceptsAdvanced melanomaEastern Cooperative Oncology Group performance statusUnresectable stage III/IV melanomaStage III/IV melanomaTreatment-related adverse eventsElevated lactate dehydrogenase levelBRAF wild-type tumorsOverall survival dataRandomized clinical trialsLactate dehydrogenase levelsAccess programBRAF-mutant tumorsRelevant patient subgroupsWild-type tumorsCombination nivolumabEligible patientsOS ratesCheckpoint inhibitorsTreatment discontinuationAdverse eventsPerformance statusUnacceptable toxicityMucosal melanomaPatient subgroupsClinical trials
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