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
2010
Clinical Experiences With Anti-CD137 and Anti-PD1 Therapeutic Antibodies
Ascierto PA, Simeone E, Sznol M, Fu YX, Melero I. Clinical Experiences With Anti-CD137 and Anti-PD1 Therapeutic Antibodies. Seminars In Oncology 2010, 37: 508-516. PMID: 21074066, DOI: 10.1053/j.seminoncol.2010.09.008.Peer-Reviewed Original ResearchConceptsDurable objective responsesPotent cellular immunityAnti-CD137 antibodyCellular immune responsesLigand PD-L1Reasonable safety profileSevere liver toxicityTumor response criteriaTransplantable murine tumorsDose-dependent effectSurface of antigenImmunostimulatory mAbsAntitumor immunityObjective responseDeath-1PD-L1Tumor immunityCellular immunitySafety profileLiver toxicityClinical activityT lymphocytesImmune responseTumor antigensAgonist antibody