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
2007
A Clinical Development Paradigm for Cancer Vaccines and Related Biologics
Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, Nichol G. A Clinical Development Paradigm for Cancer Vaccines and Related Biologics. Journal Of Immunotherapy 2007, 30: 1-15. PMID: 17198079, DOI: 10.1097/01.cji.0000211341.88835.ae.Peer-Reviewed Original ResearchConceptsTherapeutic cancer vaccinesPhase 2 trialCancer vaccinesEfficacy trialsPrinciple trialImmune responseEnd pointCytotoxic agentsCombination therapyRelated biologicsBiologic activitySingle-arm phase 2 trialRandomized phase 2 trialClinical development challengesRandomized phase 2Primary end pointStudy end pointTumor response ratePhase 3 studyPhase 3 trialClinical end pointsNovel cancer vaccinesDifferent clinical characteristicsSuch immune responsesClinical development plan