2019
Long-term follow-up of CA209-004: A phase I dose-escalation study of combined nivolumab (NIVO) and ipilimumab (IPI) in patients with advanced melanoma.
Atkins M, Kirkwood J, Wolchok J, Callahan M, Kluger H, Postow M, Segal N, Lesokhin A, Balogh A, Re S, Sznol M. Long-term follow-up of CA209-004: A phase I dose-escalation study of combined nivolumab (NIVO) and ipilimumab (IPI) in patients with advanced melanoma. Journal Of Clinical Oncology 2019, 37: 9533-9533. DOI: 10.1200/jco.2019.37.15_suppl.9533.Peer-Reviewed Original ResearchPhase I dose-escalation studyI dose-escalation studyDose-escalation studyOS ratesAdvanced melanomaIPI 3Survival rateUnresectable stage IIIECOG performance statusDiscontinuation of treatmentFavorable survival outcomesProgression-free survivalOverall survival rateLong-term survivalExploratory endpointsElevated LDHLast dosePrimary endpointSecondary endpointsStudy drugConcurrent therapyPerformance statusSurvival outcomesDisease progressionCohort 1
2017
A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk melanoma (U.S. Intergroup E1609): Preliminary safety and efficacy of the ipilimumab arms.
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. A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk melanoma (U.S. Intergroup E1609): Preliminary safety and efficacy of the ipilimumab arms. Journal Of Clinical Oncology 2017, 35: 9500-9500. DOI: 10.1200/jco.2017.35.15_suppl.9500.Peer-Reviewed Original ResearchHigh-dose interferon-alfaHigh-risk melanomaAdverse eventsAdjuvant therapyRFS analysisHigh-dose interferon alfa-2bThree-year RFS ratesTreatment related adverse eventsRelative safetyDiscontinuation of treatmentInterferon alfa-2bRelated adverse eventsCo-primary endpointsRegulatory approvalAdjuvant ipilimumabAdult ptsInoperable melanomaIpilimumab armInterferon alfaAlfa-2bRFS ratesPreliminary safetyDose levelsRecent approvalMelanoma