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
S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC).
Argiris A, Miao J, Cristea M, Chen A, Sands J, Decker R, Gettinger S, Daly M, Faller B, Albain K, Yanagihara R, Garland L, Byers L, Wang D, Koczywas M, Redman M, Kelly K, Gandara D. S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2019, 37: 8523-8523. DOI: 10.1200/jco.2019.37.15_suppl.8523.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalStage III non-small cell lung cancerAdverse eventsG3 anemiaG3 thrombocytopeniaOverall survivalUnresectable stage III non-small cell lung cancerPARP inhibitorsG3 adverse eventsG3 oral mucositisG3-4 neutropeniaG4 adverse eventsPhase II dosePlacebo-controlled trialCell lung cancerDose-finding studyPhase I partPhase IIBackbone regimenConsolidation carboplatinEvaluable patientsG3 fatigueG3 nauseaG3 neutropenia
2013
First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results.
Camidge D, Bazhenova L, Salgia R, Weiss G, Langer C, Shaw A, Narasimhan N, Dorer D, Rivera V, Zhang J, Clackson T, Haluska F, Gettinger S. First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results. Journal Of Clinical Oncology 2013, 31: 8031-8031. DOI: 10.1200/jco.2013.31.15_suppl.8031.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsAdverse eventsAdvanced malignanciesCommon grade 3/4 treatment-related adverse eventsGrade 3/4 treatment-related adverse eventsEGFR-TKI resistant NSCLCNon-small cell lung cancerTreatment-related adverse eventsALK tyrosine kinase inhibitorsPhase I/IINovel tyrosine kinase inhibitorEGFR tyrosine kinase inhibitorsDose finding phaseGrade 4 dyspneaTKI-resistant NSCLCPhase II doseFollow-up scanCell lung cancerDose-finding studyAge 60 yrAnaplastic lymphoma kinaseAnti-tumor activityEpidermal growth factor receptorGrowth factor receptorStable diseasePhase 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 I/II Study of Inhaled Doxorubicin Combined with Platinum-Based Therapy for Advanced Non–Small Cell Lung Cancer
Otterson GA, Villalona-Calero MA, Hicks W, Pan X, Ellerton JA, Gettinger SN, Murren JR. Phase I/II Study of Inhaled Doxorubicin Combined with Platinum-Based Therapy for Advanced Non–Small Cell Lung Cancer. Clinical Cancer Research 2010, 16: 2466-2473. PMID: 20371682, PMCID: PMC4262532, DOI: 10.1158/1078-0432.ccr-09-3015.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdministration, InhalationAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Large CellCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCisplatinDocetaxelDoxorubicinFemaleHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedSurvival RateTaxoidsTreatment OutcomeConceptsNon-small cell lung cancerCell lung cancerAdvanced non-small cell lung cancerDose-limiting toxicityLung cancerEvaluable patientsPhase I/II studyDose level 1Phase II dosePulmonary function testsDoses of cisplatinStable diseaseII studyProgressive diseaseExpiratory volumePulmonary functionFunction testsVital capacityPulmonary toxicityAdequate organPatientsCancerLevel 1Phase ILevel 2