2024
Pembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Leconte P, Adelberg D, Chiorean E. Pembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D. Clinical Colorectal Cancer 2024, 23: 118-127.e6. PMID: 38762348, DOI: 10.1016/j.clcc.2024.03.001.Peer-Reviewed Original ResearchMetastatic colorectal cancerObjective response rateCohort BCohort DAdverse eventsColorectal cancerT-cell-inflamed gene expression profileInvestigator-assessed objective response ratePD-L1 combined positive scoreTreatment-related adverse eventsResponse rateCombined positive scoreDose-limiting toxicityMedian follow-upTumor mutational burdenDecreased neutrophil countPrimary end pointMismatch repair-proficientStandard of careBiomarker analysisMethods PatientsRECIST v1.1PD-L1HER2 expressionMutational burden
2022
Pembrolizumab (pembro) plus binimetinib (bini) with or without chemotherapy (chemo) for metastatic colorectal cancer (mCRC): Results from KEYNOTE-651 cohorts A, C, and E.
Chen E, Kavan P, Tehfe M, Kortmansky J, Sawyer M, Chiorean E, Lieu C, Polite B, Wong L, Fakih M, Spencer K, Chaves J, Li C, Carpenter D, Leconte P, Kim R. Pembrolizumab (pembro) plus binimetinib (bini) with or without chemotherapy (chemo) for metastatic colorectal cancer (mCRC): Results from KEYNOTE-651 cohorts A, C, and E. Journal Of Clinical Oncology 2022, 40: 3573-3573. DOI: 10.1200/jco.2022.40.16_suppl.3573.Peer-Reviewed Original ResearchMetastatic colorectal cancerDose-limiting toxicityCohort ACohort ECohort CEvaluable ptsMicrosatellite stableDose levelsEnd pointDose-finding phasePrimary end pointSecondary end pointsKRAS mutation statusTotal PtCohort A.RECIST v1.1Data cutoffMulticenter trialDose escalationColorectal cancerMedian studyPembroDose reductionLimited efficacyTRAEs
2019
608P Pembrolizumab (pembro) plus mFOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC): KEYNOTE-651 cohorts B and D
Kim R, Chaves J, Kavan P, Fakih M, Kortmansky J, Spencer K, Wong L, Tehfe M, Li J, Lee M, Mayo C, Marinello P, Chiorean E. 608P Pembrolizumab (pembro) plus mFOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC): KEYNOTE-651 cohorts B and D. Annals Of Oncology 2019, 30: v229-v230. DOI: 10.1093/annonc/mdz246.085.Peer-Reviewed Original ResearchMetastatic colorectal cancerTreatment-related AEsSubsidiary of MerckCohort BCohort DDohme Corp.Merck SharpEastern Cooperative Oncology Group performance status 0/1Stage IV metastatic colorectal cancerArray BioPharmaOxaliplatin-based regimenPerformance status 0/1Phase 2 dosePrior systemic chemotherapySafety/tolerabilityObjective response ratePD-1 inhibitorsDose-limiting toxicitySmall intestinal obstructionData cutoffImmunotherapy agentsSystemic chemotherapyMethods PatientsColorectal cancerEMD Serono
2007
A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma
Duffy A, Kortmansky J, Schwartz G, Capanu M, Puleio S, Minsky B, Saltz L, O’Reilly E, Kelsen D. A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma. Annals Of Oncology 2007, 19: 86-91. PMID: 17878176, DOI: 10.1093/annonc/mdm441.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyDeoxycytidineDisease ProgressionErlotinib HydrochlorideFemaleGemcitabineHumansMaleMaximum Tolerated DoseMiddle AgedNeutropeniaPancreatic NeoplasmsProtein Kinase InhibitorsQuinazolinesRadiotherapy, AdjuvantSurvival AnalysisThrombocytopeniaTreatment OutcomeConceptsDose level 1Radiation therapyDaily erlotinibAdvanced pancreas cancerDose level 2Dose of erlotinibGemcitabine-based chemoradiationMTD of erlotinibAdvanced pancreatic cancerElevated liver enzymesPartial response rateDose-limiting toxicityPoor prognostic cancerDose delaysDose gemcitabineGemcitabine 1000Stable diseaseWeekly gemcitabineMedian survivalOverall survivalAdditional patientsPancreas cancerPancreatic cancerPancreatic adenocarcinomaLiver enzymes
2005
A Phase I Clinical Trial of the Sequential Combination of Irinotecan Followed by Flavopiridol
Shah MA, Kortmansky J, Motwani M, Drobnjak M, Gonen M, Yi S, Weyerbacher A, Cordon-Cardo C, Lefkowitz R, Brenner B, O'Reilly E, Saltz L, Tong W, Kelsen DP, Schwartz GK. A Phase I Clinical Trial of the Sequential Combination of Irinotecan Followed by Flavopiridol. Clinical Cancer Research 2005, 11: 3836-3845. PMID: 15897584, DOI: 10.1158/1078-0432.ccr-04-2651.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBilirubinCamptothecinCell Cycle ProteinsCyclin-Dependent Kinase Inhibitor p21Drug Administration ScheduleDrug InteractionsFemaleFlavonoidsHumansIntracellular Signaling Peptides and ProteinsIrinotecanMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPiperidinesTreatment OutcomeTumor Suppressor Protein p53ConceptsCombination therapyCycle 1 dose-limiting toxicitiesPhase I clinical trialDose-limiting diarrheaPhase II dosePosttreatment tumor biopsiesSignificant pharmacokinetic interactionsAdvanced solid tumorsDose-limiting toxicityPhase I trialBaseline serum bilirubinColorectal cancer xenograftsWild-type p53 tumorsMumol/LBaseline bilirubinFlavopiridol concentrationsStable diseasePartial responseI trialPharmacokinetic interactionsSerum bilirubinDifferentiation-related gene-1Responsive diseaseHepatocellular cancerCancer xenografts