2022
Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment
Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. CardioVascular And Interventional Radiology 2022, 45: 405-412. PMID: 35119481, PMCID: PMC8940827, DOI: 10.1007/s00270-021-03031-9.Peer-Reviewed Original ResearchConceptsBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseHepatocellular carcinomaCurative treatmentRECIST 1.1Primary endpointClinical benefitControl rateEastern Cooperative Oncology Group performance status 0Response rateChild-Pugh class ARandomized phase 3 studyDual primary endpointsOverall survival eventsPerformance status 0Previous systemic treatmentPD-1 inhibitorsPortal vein thrombosisPhase 3 studyResponse Evaluation CriteriaSolid Tumors 1.1LEAP-012 trial in progress: Transarterial chemoembolization (TACE) with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma (HCC)
El-Khoueiry A, Llovet J, Vogel A, Madoff D, Finn R, Ogasawara S, Ren Z, Mody K, Li J, Siegel A, Dubrovsky L, Kudo M. LEAP-012 trial in progress: Transarterial chemoembolization (TACE) with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma (HCC). Journal Of Clinical Oncology 2022, 40: tps494-tps494. DOI: 10.1200/jco.2022.40.4_suppl.tps494.Peer-Reviewed Original ResearchBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseTransarterial chemoembolizationRECIST v1.1Hepatocellular carcinomaEnd pointCurative treatmentEastern Cooperative Oncology Group performance statusDual primary end pointsExploratory end pointsPrevious systemic treatmentPD-1 inhibitorsPortal vein thrombosisPrimary end pointSecondary end pointsSecond-line therapyPhase 3 studyHealth-related qualityIntermediate hepatocellular carcinomaAdvanced hepatocellular carcinomaLimited treatment options
2013
The Combination Of Palbociclib Plus Bortezomib Is Safe and Active In Patients With Previously Treated Mantle Cell Lymphoma: Final Results Of a Phase I Trial
Martin P, DiLiberto M, Mason C, Ely S, Ruan J, Furman R, Chiron D, Huang X, Madoff D, Navi J, Lewis J, Bender A, Rodriguez A, Greenberg J, Coleman M, Chen-Kiang S, Leonard J. The Combination Of Palbociclib Plus Bortezomib Is Safe and Active In Patients With Previously Treated Mantle Cell Lymphoma: Final Results Of a Phase I Trial. Blood 2013, 122: 4393. DOI: 10.1182/blood.v122.21.4393.4393.Peer-Reviewed Original ResearchMantle cell lymphomaTreatment-related grade 3Dose level 3Dose level 4Dose level 1Phase I trialCombination of palbociclibGrade 3Day 8MCL cellsI trialCell lymphomaDose levelsCyclin D1Seattle GeneticsAdequate bone marrowDose level 2Dose of palbociclibNon-hematologic toxicitiesGrade 4 neutropeniaNausea/vomitingSpeakers bureauDuration of responseCycle 2Novel therapeutic combinations