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dc.contributor.authorLong, Georgina V-
dc.contributor.authorRobert, Caroline-
dc.contributor.authorButler, Marcus O-
dc.contributor.authorCouture, Felix-
dc.contributor.authorCarlino, Matteo S-
dc.contributor.authorO'Day, Steven-
dc.contributor.authorAtkinson, Victoria-
dc.contributor.authorCebon, Jonathan S-
dc.contributor.authorBrown, Michael P-
dc.contributor.authorDalle, Stephane-
dc.contributor.authorHill, Andrew G-
dc.contributor.authorGibney, Geoffrey T-
dc.contributor.authorMcCune, Steven-
dc.contributor.authorMenzies, Alexander M-
dc.contributor.authorNiu, Cuizhen-
dc.contributor.authorIbrahim, Nageatte-
dc.contributor.authorHomet Moreno, Blanca-
dc.contributor.authorDiab, Adi-
dc.identifier.citationClinical Cancer Research 2021; online first: 1 Julyen
dc.description.abstractStandard-dose pembrolizumab plus alternative-dose ipilimumab (1 mg/kg Q3W for 4 doses) was tolerable and had robust antitumor activity in advanced melanoma in cohort B of the phase 1 KEYNOTE-029 study. Cohort C evaluated standard-dose pembrolizumab with two other alternative ipilimumab regimens. Patients with treatment-naive unresectable stage III/IV melanoma were randomly assigned 1:1 to pembrolizumab 200 mg Q3W for {less than or equal to}24 months plus ipilimumab 50 mg Q6W for 4 doses (PEM200+IPI50), or the same pembrolizumab regimen plus ipilimumab 100 mg Q12W for 4 doses (PEM200+IPI100). Primary end points were incidence of grade 3-5 treatment-related adverse events (TRAEs) and objective response rate (ORR) per RECIST v1.1 by independent central review. Per protocol-defined thresholds, grade 3-5 TRAE incidence {less than or equal to}26% indicated meaningful toxicity reduction and ORR {greater than or equal to}48% indicated no decrease in efficacy versus data reported for other PD-1 inhibitor/ipilimumab combinations. Median follow-up on February 18, 2019, was 16.3 months in PEM200+IPI50 (N=51) and 16.4 months in PEM200+IPI100 (N=51). Grade 3-5 TRAEs occurred in 12 (24%) patients in PEM200+IPI50 and 20 (39%) in PEM200+IPI100. One patient in PEM200+IPI50 died from treatment-related autoimmune myocarditis. Immune-mediated AEs or infusion reactions occurred in 21 (42%) patients in PEM200+IPI50 and 28 (55%) in PEM200+IPI100. ORR was 55% in PEM200+IPI50; 61% in PEM200+IPI100. Pembrolizumab 200 mg Q3W plus ipilimumab 50 mg Q6W or 100 mg Q12W demonstrated antitumor activity above the predefined threshold; pembrolizumab plus ipilimumab 50 mg Q6W had lower incidence of grade 3-5 TRAEs than the predefined threshold, suggesting a reduction in toxicity.en
dc.titleStandard-Dose Pembrolizumab Plus Alternate-Dose Ipilimumab in Advanced Melanoma: KEYNOTE-029 Cohort 1C, a Phase 2 Randomized Study of Two Dosing Schedules.en
dc.typeJournal Articleen
dc.identifier.journaltitleClinical Cancer Researchen
dc.identifier.affiliationMSD Chinaen
dc.identifier.affiliationMelanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals.en
dc.identifier.affiliationINSERM U981, Institut Gustave Roussyen
dc.identifier.affiliationMedical Oncology, Princess Margaret Cancer Centreen
dc.identifier.affiliationUniversité Lavalen
dc.identifier.affiliationMedicine, Melanoma Institute Australia, The University of Sydney, Blacktown Hospital, and Crown Princess Mary Cancer Centre, Westmead Hospitalen
dc.identifier.affiliationJohn Wayne Cancer Institute at Providence Saint John's Health Centeren
dc.identifier.affiliationDivision of Cancer Services, Princess Alexandra Hospitalen
dc.identifier.affiliationOlivia Newton-John Cancer Research Instituteen
dc.identifier.affiliationDepartment of Medical Oncology, Royal Adelaide Hospitalen
dc.identifier.affiliationiNSERM 590, Claude Bernard Lyon Universityen
dc.identifier.affiliationOncology, Tasman Oncology Researchen
dc.identifier.affiliationMedical Oncology, Georgetown Lombardi Comprehensive Cancer Centeren
dc.identifier.affiliationMedical Oncology, WellStar Health Systemen
dc.identifier.affiliationMelanoma Institute Australia, The University of Sydney and Royal North Shore and Mater Hospitalsen
dc.identifier.affiliationOncology, Merck Research Laboratoriesen
dc.identifier.affiliationMerck & Co., Incen
dc.identifier.affiliationMelanoma Medical Oncology, The University of Texas MD Anderson Cancer Centeren
dc.identifier.pubmedid34210681, Jonathan S
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.languageiso639-1en- Newton-John Cancer Research Institute-
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