2022
235 (PB115) Phase II trial of afatinib in patients with EGFR-mutated solid tumors excluding lung cancer: results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Reckamp K, Song Z, Gettinger S, Mitchell E, Wright J, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Conley B, Arteaga C, Harris L, O’Dwyer P, Chen A, Flaherty K. 235 (PB115) Phase II trial of afatinib in patients with EGFR-mutated solid tumors excluding lung cancer: results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. European Journal Of Cancer 2022, 174: s84-s85. DOI: 10.1016/s0959-8049(22)01023-1.Peer-Reviewed Original Research
2021
P14.05 Phase 2, Study of Iovance Autologous Tumor Infiltrating Lymphocytes (Lifileucel, LN-144, LN-145, LN-145-S1) In Patients With Solid Tumors
Gettinger S, Kluger H, Schoenfeld A, Warner A, He K, Sukari A, Thomas S, Doger B, Lee S, Haefliger S, Goldberg Z, Cacovean A, Fiaz R, Chen G, Jagasia M, Finckenstein F, Fardis M, Jimeno A. P14.05 Phase 2, Study of Iovance Autologous Tumor Infiltrating Lymphocytes (Lifileucel, LN-144, LN-145, LN-145-S1) In Patients With Solid Tumors. Journal Of Thoracic Oncology 2021, 16: s1012-s1013. DOI: 10.1016/j.jtho.2021.08.335.Peer-Reviewed Original ResearchNTRK1 Fusions identified by non-invasive plasma next-generation sequencing (NGS) across 9 cancer types
Rolfo C, Drilon A, Hong D, McCoach C, Dowlati A, Lin JJ, Russo A, Schram AM, Liu SV, Nieva JJ, Nguyen T, Eshaghian S, Morse M, Gettinger S, Mobayed M, Goldberg S, Araujo-Mino E, Vidula N, Bardia A, Subramanian J, Sashital D, Stinchcombe T, Kiedrowski L, Price K, Gandara DR. NTRK1 Fusions identified by non-invasive plasma next-generation sequencing (NGS) across 9 cancer types. British Journal Of Cancer 2021, 126: 514-520. PMID: 34480094, PMCID: PMC8811064, DOI: 10.1038/s41416-021-01536-1.Peer-Reviewed Original ResearchConceptsPlasma next-generation sequencingNTRK1 fusionsTumor typesAdvanced-stage solid tumorsNTRK fusion-positive tumorsTarget resistance mechanismsTissue-based testingHigh positive predictive valuePrimary tumor typeIdentification of patientsNon-invasive screening methodNext-generation sequencingFusion-positive tumorsPositive predictive valueDurable responsesPediatric patientsNTRK fusionsDrivers of carcinogenesisClinical dataTRK inhibitorsClinical practiceCtDNA analysisPredictive valueSolid tumorsOncogenic drivers187TiP Phase II, multicenter study of autologous tumor infiltrating lymphocytes (TIL, LN 144/LN-145/LN-145-S1) in patients with solid tumours
Gettinger S, Kluger H, Schoenfeld A, Warner A, He K, Sukari A, Thomas S, de Spéville B, Lee S, Haefliger S, Goldberg Z, Cacovean A, Fiaz R, Chen G, Jagasia M, Finckenstein F, Fardis M, Jimeno A. 187TiP Phase II, multicenter study of autologous tumor infiltrating lymphocytes (TIL, LN 144/LN-145/LN-145-S1) in patients with solid tumours. Journal Of Thoracic Oncology 2021, 16: s799-s800. DOI: 10.1016/s1556-0864(21)02029-3.Peer-Reviewed Original Research
2020
Bempegaldesleukin (NKTR-214) plus Nivolumab in Patients with Advanced Solid Tumors: Phase I Dose-Escalation Study of Safety, Efficacy, and Immune Activation (PIVOT-02)
Diab A, Tannir NM, Bentebibel SE, Hwu P, Papadimitrakopoulou V, Haymaker C, Kluger HM, Gettinger SN, Sznol M, Tykodi SS, Curti BD, Tagliaferri MA, Zalevsky J, Hannah AL, Hoch U, Aung S, Fanton C, Rizwan A, Iacucci E, Liao Y, Bernatchez C, Hurwitz ME, Cho DC. Bempegaldesleukin (NKTR-214) plus Nivolumab in Patients with Advanced Solid Tumors: Phase I Dose-Escalation Study of Safety, Efficacy, and Immune Activation (PIVOT-02). Cancer Discovery 2020, 10: 1158-1173. PMID: 32439653, DOI: 10.1158/2159-8290.cd-19-1510.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellFemaleGene Expression Regulation, NeoplasticHumansImmune Checkpoint InhibitorsImmunotherapyInterleukin-2Kidney NeoplasmsLung NeoplasmsLymphocyte CountLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedNivolumabPolyethylene GlycolsProgrammed Cell Death 1 ReceptorTreatment OutcomeYoung AdultConceptsTreatment-related adverse eventsAdvanced solid tumorsPD-L1 statusSolid tumorsGrade 3/4 treatment-related adverse eventsPD-1/PD-L1 blockadeCommon treatment-related adverse eventsPhase I dose-escalation trialPoor prognostic risk factorsTotal objective response rateI dose-escalation studyI dose-escalation trialLongitudinal tumor biopsiesPD-L1 blockadeT-cell enhancementTreatment-related deathsObjective response ratePhase II doseDose-escalation studyDose-escalation trialDose-limiting toxicityFlu-like symptomsPrognostic risk factorsTumor-infiltrating lymphocytesCytotoxicity of CD8
2019
Incidence of pancreatitis with the use of immune checkpoint inhibitors (ICI) in advanced cancers: A systematic review and meta-analysis
George J, Bajaj D, Sankaramangalam K, Yoo JW, Joshi NS, Gettinger S, Price C, Farrell JJ. Incidence of pancreatitis with the use of immune checkpoint inhibitors (ICI) in advanced cancers: A systematic review and meta-analysis. Pancreatology 2019, 19: 587-594. PMID: 31076344, DOI: 10.1016/j.pan.2019.04.015.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsIncidence of pancreatitisImmune side effectsPD-1 inhibitorsLipase elevationCheckpoint inhibitorsClinical trialsSide effectsSystematic reviewCTLA-4 agentsGrade 2 pancreatitisCTLA-4 inhibitorsLong-term complicationsNon-melanoma cancersICI combinationsICI useTerm complicationsAdvanced cancerTrue incidenceCTLA-4Appropriate treatmentPancreatitisSolid tumorsTumor typesPatients
2018
NKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT.
Diab A, Hurwitz M, Cho D, Papadimitrakopoulou V, Curti B, Tykodi S, Puzanov I, Ibrahim N, Tolaney S, Tripathy D, Gao J, Siefker-Radtke A, Clemens W, Tagliaferri M, Gettinger S, Kluger H, Larkin J, Grignani G, Sznol M, Tannir N. NKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT. Journal Of Clinical Oncology 2018, 36: 3006-3006. DOI: 10.1200/jco.2018.36.15_suppl.3006.Peer-Reviewed Original Research
2015
Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors
Abu-Khalaf MM, Baumgart MA, Gettinger SN, Doddamane I, Tuck DP, Hou S, Chen N, Sullivan C, Lezon-Geyda K, Zelterman D, Hatzis C, Deshpande H, Digiovanna MP, Azodi M, Schwartz PE, Harris LN. Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors. Cancer 2015, 121: 1817-1826. PMID: 25649370, DOI: 10.1002/cncr.29254.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityIntravenous nab-paclitaxelPhase 1b studyAdvanced solid tumorsNab-paclitaxelFDG activityDay 1Solid tumorsNanoparticle albumin-bound paclitaxelMammalian targetWeekly oral doseAcceptable safety profileRapamycin inhibitor sirolimusAlbumin-bound paclitaxelClinical trial endpointsExploratory gene expression analysisPositron emission tomographyStable diseaseTaxane therapyPartial responseWeekly doseComplete responseOral sirolimusPharmacodynamic assessmentOral dose
2014
Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients
Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 2014, 515: 563-567. PMID: 25428504, PMCID: PMC4836193, DOI: 10.1038/nature14011.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkersChemokine CX3CL1Clinical ProtocolsCTLA-4 AntigenDisease-Free SurvivalFemaleGene Expression Regulation, NeoplasticHumansImmunotherapyLymphocytes, Tumor-InfiltratingMaleMiddle AgedNeoplasmsTreatment OutcomeYoung Adult
2013
Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial.
Topalian S, Sznol M, Brahmer J, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Powderly J, Carvajal R, Sosman J, Atkins M, Antonia S, Spigel D, Lawrence D, Kollia G, Gupta A, Wigginton J, Hodi F. Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial. Journal Of Clinical Oncology 2013, 31: 3002-3002. DOI: 10.1200/jco.2013.31.15_suppl.3002.Peer-Reviewed Original ResearchAdvanced solid tumorsLong-term safetySolid tumorsNon-small cell lung cancerLong-term safety profileDrug-related AEsDrug-related pneumonitisCo-inhibitory receptorsPhase III trialsPhase I trialCell lung cancerOngoing clinical developmentActivated T cellsCohort expansionMedian OSRECIST 1.0Efficacy outcomesUnacceptable toxicityIII trialsDeath-1Dose escalationI trialPD-1G3/G4Safety profilePhase I Study of the Hedgehog Pathway Inhibitor IPI-926 in Adult Patients with Solid Tumors
Jimeno A, Weiss GJ, Miller WH, Gettinger S, Eigl BJ, Chang AL, Dunbar J, Devens S, Faia K, Skliris G, Kutok J, Lewis KD, Tibes R, Sharfman WH, Ross RW, Rudin CM. Phase I Study of the Hedgehog Pathway Inhibitor IPI-926 in Adult Patients with Solid Tumors. Clinical Cancer Research 2013, 19: 2766-2774. PMID: 23575478, PMCID: PMC3694426, DOI: 10.1158/1078-0432.ccr-12-3654.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlanine TransaminaseAlopeciaArea Under CurveAspartate AminotransferasesDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleFollow-Up StudiesHedgehog ProteinsHumansMaleMetabolic Clearance RateMiddle AgedNauseaNeoplasmsSignal TransductionSpasmTreatment OutcomeVeratrum AlkaloidsConceptsBasal cell carcinomaDose-limiting toxicityInhibitor-naïve patientsIPI-926Alanine aminotransferaseSolid tumorsAspartate aminotransferaseAccelerated titration scheduleDose-escalation cohortsPhase II doseResponse Evaluation CriteriaSingle-agent activityHuman phase ISolid Tumors assessmentHematologic toxicityStarting doseAdult patientsStandard therapyMuscle spasmTitration scheduleReversible elevationCell carcinomaQD dosingTumor assessmentPharmacokinetic profile
2010
Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors
Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors. Clinical Cancer Research 2010, 16: 358-366. PMID: 20028764, PMCID: PMC4211604, DOI: 10.1158/1078-0432.ccr-09-2103.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsDrug-related grade 3Vascular endothelial growth factor trapDose of afliberceptDose-escalation studyDose-proportional increaseInjection site reactionsPhase 1 studyManageable side effectsVascular endothelial growth factorWarrants further evaluationFavorable pharmacokinetic profileProgression of diseaseNovel antiangiogenic agentsEndothelial growth factorCommon toxicitiesStable diseasePulmonary embolismCerebral ischemiaSubcutaneous dosesSafety profileSingle doseSite reactionsSubcutaneous formulation
2009
A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors
Deshpande H, Gettinger S, Rowen E, Abu-Khalaf M, Clarke J, Burns A, Kelly W. A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors. Journal Of Clinical Oncology 2009, 27: e13501-e13501. DOI: 10.1200/jco.2009.27.15_suppl.e13501.Peer-Reviewed Original ResearchNanoparticle albumin-bound paclitaxelAlbumin-bound paclitaxelCohort 2Cohort 3Cohort 1Platinum agentsSolid tumorsDay 14Common severe adverse eventsGrade 3 anemiaMedian age 51Grade 4 neutropeniaStandard chemotherapy regimenAdvanced solid tumorsPhase 2 studySevere adverse eventsNeurological side effectsCycle 1Stable diseaseChemotherapy regimenDay 1 treatmentAdvanced malignanciesAdverse eventsPartial responseProgressive disease