2019
Lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with advanced melanoma previously exposed to anti–PD-1/PD-L1 agents: Phase 2 LEAP-004 study.
Arance Fernandez A, Ascierto P, Carlino M, Daud A, Eggermont A, Hauschild A, Kluger H, Taylor M, Smith A, Chen K, Krepler C, Diede S, O'Day S. Lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with advanced melanoma previously exposed to anti–PD-1/PD-L1 agents: Phase 2 LEAP-004 study. Journal Of Clinical Oncology 2019, 37: tps9594-tps9594. DOI: 10.1200/jco.2019.37.15_suppl.tps9594.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitor therapyPD-L1 inhibitor therapyPD-1 inhibitorsRECIST v1.1Advanced melanomaLast doseInhibitor therapyAnti-PD-1/PD-L1 agentsKey secondary end pointPrimary efficacy end pointEnd pointActive autoimmune diseaseAdequate organ functionBaseline tumor samplesECOG PS 0/1Exploratory biomarker analysisNCI CTCAE v4.0PD-L1 agentsUnresectable stage IIIAntitumor activityEfficacy end pointSecondary end pointsWeeks of therapyPhase 2 trialKey inclusion criteriaLong-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
Sarcoidosis Following Anti-PD-1 and Anti-CTLA-4 Therapy for Metastatic Melanoma
Reddy SB, Possick JD, Kluger HM, Galan A, Han D. Sarcoidosis Following Anti-PD-1 and Anti-CTLA-4 Therapy for Metastatic Melanoma. Journal Of Immunotherapy 2017, 40: 307-311. PMID: 28737620, DOI: 10.1097/cji.0000000000000181.Peer-Reviewed Case Reports and Technical NotesMeSH KeywordsAdrenal Cortex HormonesAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsAutoimmunityCTLA-4 AntigenDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunotherapyIpilimumabLungMelanomaMiddle AgedNivolumabProgrammed Cell Death 1 ReceptorSarcoidosisSkinSkin NeoplasmsTreatment OutcomeConceptsAnti-PD-1 therapyImmune checkpoint inhibitorsStage IV melanomaCheckpoint inhibitorsOncologic responseSevere immune-related adverse effectsImmune checkpoint inhibitor therapyImmune-related adverse effectsAnti PD-1Severe pulmonary manifestationsCheckpoint inhibitor therapyPD-1 inhibitorsDevelopment of sarcoidosisAutoimmune tendencyCorticosteroid treatmentLast dosePulmonary manifestationsCutaneous sarcoidosisRare complicationInhibitor therapyRadiologic findingsPatient's symptomsMetastatic melanomaPotential complicationsSarcoidosisStereotactic radiosurgery of early melanoma brain metastases after initiation of anti-CTLA-4 treatment is associated with improved intracranial control
An Y, Jiang W, Kim BYS, Qian JM, Tang C, Fang P, Logan J, D'Souza NM, Haydu LE, Wang XA, Hess KR, Kluger H, Glitza IC, Mahajan A, Welsh JW, Lin SH, Yu JB, Davies MA, Hwu P, Sulman EP, Brown PD, Chiang VLS, Li J. Stereotactic radiosurgery of early melanoma brain metastases after initiation of anti-CTLA-4 treatment is associated with improved intracranial control. Radiotherapy And Oncology 2017, 125: 80-88. PMID: 28916225, DOI: 10.1016/j.radonc.2017.08.009.Peer-Reviewed Original ResearchConceptsIntracranial disease controlNew brain metastasesIntracranial controlStereotactic radiosurgeryBrain metastasesOverall survivalDisease controlLymphocyte countMulti-institutional retrospective analysisYale-New Haven HospitalMD Anderson cohortMelanoma brain metastasesAbsolute lymphocyte countAntitumor immune responseImmune checkpoint blockadeMetastatic melanoma patientsComplete blood countTumor-specific antigensIndependent validation cohortMulti-institutional studyIpilimumab therapyMedian followLast doseCheckpoint blockadeIntracranial recurrence