2020
Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial
Goldberg SB, Schalper KA, Gettinger SN, Mahajan A, Herbst RS, Chiang AC, Lilenbaum R, Wilson FH, Omay SB, Yu JB, Jilaveanu L, Tran T, Pavlik K, Rowen E, Gerrish H, Komlo A, Gupta R, Wyatt H, Ribeiro M, Kluger Y, Zhou G, Wei W, Chiang VL, Kluger HM. Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial. The Lancet Oncology 2020, 21: 655-663. PMID: 32251621, PMCID: PMC7380514, DOI: 10.1016/s1470-2045(20)30111-x.Peer-Reviewed Original ResearchConceptsBrain metastasis responseYale Cancer CenterPD-L1 expressionPhase 2 trialUntreated brain metastasesBrain metastasesAdrenal insufficiencyAdverse eventsMetastasis responseCNS diseaseCancer CenterCohort 2Cohort 1Eastern Cooperative Oncology Group performance statusTreatment-related serious adverse eventsModified Response Evaluation CriteriaStage IV NSCLCTreatment-related deathsAcute kidney injuryPD-1 blockadeSerious adverse eventsSolid Tumors criteriaPhase 2 studyProportion of patientsResponse Evaluation Criteria
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