United States Intergroup E1609: A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon-α2b for resected high-risk melanoma.
Tarhini A, Lee S, Hodi F, Rao U, Cohen G, Hamid O, Hutchins L, Sosman J, Kluger H, Sondak V, Koon H, Lawrence D, Kendra K, Minor D, Lee C, Albertini M, Flaherty L, Petrella T, Kirkwood J. United States Intergroup E1609: A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon-α2b for resected high-risk melanoma. Journal Of Clinical Oncology 2019, 37: 9504-9504. DOI: 10.1200/jco.2019.37.15_suppl.9504.Peer-Reviewed Original ResearchRelapse-free survivalHigh-risk melanomaOverall survivalAdjuvant therapyAdverse events grade 3High-dose interferon-α2bPhase III adjuvant trialActive control regimenMelanoma adjuvant therapySystemic adjuvant therapySignificant OS differenceCo-primary endpointsAdjuvant ipilimumabAdjuvant standardRFS benefitsAdjuvant trialsTreatment discontinuationData cutoffPrimary endpointITT analysisPatient accrualControl regimenProtocol criteriaGrade 3OS difference