2016
Efficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis
D'Angelo SP, Larkin J, Sosman JA, Lebbé C, Brady B, Neyns B, Schmidt H, Hassel JC, Hodi FS, Lorigan P, Savage KJ, Miller WH, Mohr P, Marquez-Rodas I, Charles J, Kaatz M, Sznol M, Weber JS, Shoushtari AN, Ruisi M, Jiang J, Wolchok JD. Efficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis. Journal Of Clinical Oncology 2016, 35: 226-235. PMID: 28056206, PMCID: PMC5559888, DOI: 10.1200/jco.2016.67.9258.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalObjective response rateProgression-free survivalMucosal melanomaCutaneous melanomaNivolumab monotherapyAnti-programmed death-1 therapyResponse rateTreatment-related adverse eventsSafety of nivolumabPhase III trialsRare melanoma subtypeNivolumab AloneAdverse eventsIII trialsSafety profileAggressive malignancyCombination therapyConventional therapyPooled analysisPoor responseClinical studiesGrade 3IpilimumabMelanoma subtypes
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
2013
Ipilimumab-induced Perforating Colitis
Mitchell KA, Kluger H, Sznol M, Hartman DJ. Ipilimumab-induced Perforating Colitis. Journal Of Clinical Gastroenterology 2013, 47: 781-785. PMID: 23632354, PMCID: PMC6091636, DOI: 10.1097/mcg.0b013e31828f1d51.Peer-Reviewed Original ResearchConceptsIpilimumab-induced colitisSteroid therapyHistologic findingsT-lymphocyte-associated antigen 4Common side effectsAssociated histologic findingsBowel perforationSubtotal colectomyMucosal biopsiesSegmental resectionStandard treatmentAntigen-4Metastatic melanomaColitisSide effectsMonoclonal antibodiesTherapyIpilimumabColectomyDiarrheaPatientsPerforationTreatmentResectionBiopsyNivolumab plus Ipilimumab in Advanced Melanoma
Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A, Kronenberg SA, Agunwamba BU, Zhang X, Lowy I, Inzunza HD, Feely W, Horak CE, Hong Q, Korman AJ, Wigginton JM, Gupta A, Sznol M. Nivolumab plus Ipilimumab in Advanced Melanoma. New England Journal Of Medicine 2013, 369: 122-133. PMID: 23724867, PMCID: PMC5698004, DOI: 10.1056/nejmoa1302369.Peer-Reviewed Original ResearchConceptsObjective response ratePhase 1 trialAdverse eventsConcurrent therapyAdvanced melanomaTumor regressionClinical activityGrade 3Distinct immunologic mechanismsManageable safety profileProlongs overall survivalDurable tumor regressionSupportive preclinical dataRegimen groupImmunologic mechanismsObjective responseOverall survivalIntravenous dosesSafety profileTumor reductionPreclinical dataIpilimumabNivolumabPatientsMaximum doses