2025
Datopotamab deruxtecan (Dato-DXd) in locally advanced/metastatic urothelial cancer: Updated results from the phase 1 TROPIONPanTumor01 study.
Meric-Bernstam F, Alhalabi O, Lisberg A, Drakaki A, Garmezy B, Kogawa T, Spira A, Salkeni M, Gao X, Tolcher A, Bhave M, Doroshow D, Hoffman-Censits J, Klauss G, Kaga Y, Kakurai Y, Kojima T. Datopotamab deruxtecan (Dato-DXd) in locally advanced/metastatic urothelial cancer: Updated results from the phase 1 TROPIONPanTumor01 study. Journal Of Clinical Oncology 2025, 43: 663-663. DOI: 10.1200/jco.2025.43.5_suppl.663.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsBlinded independent central reviewProgression-free survivalDuration of responsePartial responseIndependent central reviewComplete responseConfirmed ORRUrothelial cancerCentral reviewMedian duration of responseMedian progression-free survivalResponse rateImmune checkpoint inhibitorsInterstitial lung disease/pneumonitisTreatment-related AEsMedian follow-upSolid tumor typesAntibody-drug conjugatesPrimary study objectiveCheckpoint inhibitorsDose interruptionPretreated ptsStable diseaseData cutoff
2024
Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study
Vazquez E, Ross J, Gross C, Childers K, Bamford S, Ritchie J, Waldstreicher J, Krumholz H, Wallach J. Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study. Clinical Trials 2024 DOI: 10.1177/17407745241304355.Peer-Reviewed Original ResearchDatopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study
Bardia A, Krop I, Kogawa T, Juric D, Tolcher A, Hamilton E, Mukohara T, Lisberg A, Shimizu T, Spira A, Tsurutani J, Damodaran S, Papadopoulos K, Greenberg J, Kobayashi F, Zebger-Gong H, Wong R, Kawasaki Y, Nakamura T, Meric-Bernstam F. Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study. Journal Of Clinical Oncology 2024, 42: 2281-2294. PMID: 38652877, PMCID: PMC11210948, DOI: 10.1200/jco.23.01909.Peer-Reviewed Original ResearchTriple-negative BCHR+/HER2- BCBreast cancerHormone receptor-positive/human epidermal growth factor receptor 2-negativeAll-causality treatment-emergent adverse eventsMedian duration of responseTopoisomerase I inhibitor payloadTreatment-emergent adverse eventsBlinded independent central reviewTriple-negative breast cancerDose-expansion studyProgression-free survivalDuration of responsePhase III studyIndependent central reviewTreating solid tumorsPrimary study objectiveAntibody-drug conjugatesDose escalationData cutoffTriple-negativeBC cohortEvaluation of antitumor activityIII studiesMedian duration
2023
Prostate cancer risk stratification using magnetic resonance imaging–ultrasound fusion vs systematic prostate biopsy
Khajir G, Press B, Lokeshwar S, Ghabili K, Rahman S, Gardezi M, Washington S, Cooperberg M, Sprenkle P, Leapman M. Prostate cancer risk stratification using magnetic resonance imaging–ultrasound fusion vs systematic prostate biopsy. JNCI Cancer Spectrum 2023, 7: pkad099. PMID: 38085220, PMCID: PMC10733209, DOI: 10.1093/jncics/pkad099.Peer-Reviewed Original ResearchConceptsMagnetic resonance imaging-ultrasound fusionMRF-TBLow-risk diseaseSystematic biopsyLower riskRisk groupingProstate biopsyActive surveillanceHigh riskProstate cancer risk stratificationIntermediate-risk criteriaIntermediate-risk diseaseSystematic prostate biopsyCancer risk stratificationPrimary study objectiveNCCN guidelinesImage-guided approachLocalized cancerRisk stratificationBenign findingsProstate cancerClinical riskDiagnostic yieldRetrospective analysisBiopsySelf-Management and Glycemic Targets in Adult Haitian Immigrants With Type 2 Diabetes
Magny-Normilus C, Whittemore R, Nunez-Smith M, Lee C, Schnipper J, Wexler D, Sanders J, Grey M. Self-Management and Glycemic Targets in Adult Haitian Immigrants With Type 2 Diabetes. Nursing Research 2023, 72: 211-217. PMID: 36929756, PMCID: PMC10121794, DOI: 10.1097/nnr.0000000000000649.Peer-Reviewed Original ResearchConceptsType 2 diabetesSelf-management behaviorsGlycemic targetsSelf-management education programDiabetes self-management education programT2D-related complicationsHaitian immigrantsPrimary study objectiveResearch Electronic Data CaptureSelf-management practicesChronic conditionsGlucose variabilityContinuous glucose monitorMultiple recruitment methodsPhysical activityElevated riskElectronic data captureDisproportionate burdenU.S. adultsT2DDiabetesSelf-ManagementRecruitment methodsStudy objectiveGlucose monitor
2022
Distribution of NCCN risk classifications using MRI-ultrasound fusion versus systematic 12 core biopsies.
Khajir G, Press B, Levi A, Sprenkle P, Leapman M. Distribution of NCCN risk classifications using MRI-ultrasound fusion versus systematic 12 core biopsies. Journal Of Clinical Oncology 2022, 40: 283-283. DOI: 10.1200/jco.2022.40.6_suppl.283.Peer-Reviewed Original ResearchMRI-ultrasound fusion biopsyNCCN risk classificationMRI-ultrasound fusionFusion biopsyLower riskActive surveillanceNCCN riskSystematic biopsyCore biopsyRisk classificationFirst-time biopsyInitial active surveillanceProportion of patientsMajority of patientsEra of MRIPrimary study objectiveProstate cancer risk classificationNCCN definitionsMedian PSASurveillance biopsiesBiopsy cohortRetrospective studySingle institutionProstate cancerBiopsy
2019
ATIM-17. A PHASE I TRIAL OF HYPOFRACTIONATED STEREOTACTIC IRRADIATION (HFSRT) COMBINED WITH NIVOLUMAB (NIVO), IPILIMUMAB (IPI) AND BEVACIZUMAB (BEV) IN PATIENTS (PTS) WITH RECURRENT HIGH GRADE GLIOMAS
Sahebjam S, Forsyth P, Tran N, Etame A, Arrington J, Jaglal M, Mokhtari S, MacAulay R, Wicklund M, Evernden B, Gatewood T, Robinson T, Raval R, Yu M. ATIM-17. A PHASE I TRIAL OF HYPOFRACTIONATED STEREOTACTIC IRRADIATION (HFSRT) COMBINED WITH NIVOLUMAB (NIVO), IPILIMUMAB (IPI) AND BEVACIZUMAB (BEV) IN PATIENTS (PTS) WITH RECURRENT HIGH GRADE GLIOMAS. Neuro-Oncology 2019, 21: vi5-vi5. PMCID: PMC6847102, DOI: 10.1093/neuonc/noz175.017.Peer-Reviewed Original ResearchGrade 1 elevationExpansion cohortSafety cohortPD-1/PDLStrong pre-clinical evidencesAnti-tumor immune responseRecurrent high-grade gliomaPhase IDose-expansion cohortsGrade 1 anorexiaGrade 1 diarrheaRT treatment fieldUse of corticosteroidsPre-clinical evidenceHigh-grade gliomasPrimary study objectiveCommon toxicitiesEligible ptsPrior RTSecondary endpointsFlat doseRecurrent tumorsGrade IIITumor regressionEfficacy dataSafety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab
Hamid O, Molinero L, Bolen CR, Sosman JA, Muñoz-Couselo E, Kluger HM, McDermott DF, Powderly J, Sarkar I, Ballinger M, Fassò M, O'Hear C, Chen DS, Hegde PS, Hodi FS. Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Clinical Cancer Research 2019, 25: 6061-6072. PMID: 31358540, DOI: 10.1158/1078-0432.ccr-18-3488.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorFatigueFemaleFeverFollow-Up StudiesHumansMaleMelanomaMiddle AgedPrognosisProgression-Free SurvivalPruritusRetrospective StudiesSeverity of Illness IndexSkinSkin NeoplasmsT-Lymphocytes, CytotoxicTranscriptomeYoung AdultConceptsTreatment-related adverse eventsAdverse eventsOverall survivalMetastatic melanomaCommon treatment-related adverse eventsMost treatment-related adverse eventsAntitumor T-cell activityMeaningful long-term survivalActivity of atezolizumabEfficacy-evaluable patientsPhase Ia studyTreatment-related deathsMedian overall survivalPD-L1 expressionProgression-free survivalCohort of patientsPhase I trialT cell activityOverall response rateBiological correlatesLong-term safetyLong-term survivalPrimary study objectiveDurable responsesGrade 1/2
2018
ATIM-08. A PHASE I TRIAL OF PEMBROLIZUMAB AND VORINOSTAT COMBINED WITH TEMOZOLOMIDE AND RADIATION THERAPY FOR NEWLY DIAGNOSED GLIOBLASTOMA (NCT03426891)
Sahebjam S, Forsyth P, Tran N, Mokhtari S, Arrington J, Jaglal M, Etame A, Liu J, Wicklund M, Gatewood T, Macaulay R, Robinson T, Yu M. ATIM-08. A PHASE I TRIAL OF PEMBROLIZUMAB AND VORINOSTAT COMBINED WITH TEMOZOLOMIDE AND RADIATION THERAPY FOR NEWLY DIAGNOSED GLIOBLASTOMA (NCT03426891). Neuro-Oncology 2018, 20: vi2-vi2. PMCID: PMC6216125, DOI: 10.1093/neuonc/noy148.005.Peer-Reviewed Original ResearchAdverse eventsPD-1/PD-L1 antibodiesDay 1Sequential dose-escalation cohortsOngoing phase I trialDose level 2Dose-escalation cohortsCommon adverse eventsDose level 1Phase II doseMonth survival ratePD-L1 antibodiesPhase I trialDose-escalation designPrimary study objectiveTumor immune recognitionPre-clinical experimentsEligible ptsMaintenance temozolomideSafety cohortConcurrent radiotherapySecondary endpointsEscalation cohortsI trialEscalation design
2017
Nivolumab combined with hypofractionated stereotactic irradiation (HFSRT) for patients with recurrent high grade gliomas: A phase I trial (NCT02829931).
Sahebjam S, Forsyth P, Arrington J, Tran N, Jaglal M, Mokhtari S, Long W, Macaulay R, Wicklund M, Drury-Sibiga A, Gatewood T, Robinson T, Raval R, Yu M. Nivolumab combined with hypofractionated stereotactic irradiation (HFSRT) for patients with recurrent high grade gliomas: A phase I trial (NCT02829931). Journal Of Clinical Oncology 2017, 35: tps2084-tps2084. DOI: 10.1200/jco.2017.35.15_suppl.tps2084.Peer-Reviewed Original ResearchHigh-grade gliomasPhase I trialGrade gliomasI trialPD-1PD-L1Grade IIIAnti-PD-1/PD-L1 blockadePD-1/PD-L1 blockadeRecurrent high-grade gliomaOngoing phase I trialDose-expansion cohortsPD-L1 blockadePrior radiation therapyTolerability of nivolumabGroup of patientsImmune checkpoint pathwaysLimited treatment optionsPreliminary antitumor activityOrthotopic murine modelLong-term survivalPrimary study objectiveIgG4 monoclonal antibodyNivolumab monotherapySafety cohortA randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB).
Anders C, Murthy R, Hamilton E, Borges V, Cameron D, Carey L, Müller V, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pivot X, Pegram M, Slamon D, Hurvitz S, Tsai M, Winer E. A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB). Journal Of Clinical Oncology 2017, 35: tps1107-tps1107. DOI: 10.1200/jco.2017.35.15_suppl.tps1107.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast carcinomaBrain metsIndependent data monitoring committeeClinical benefit ratePhase 1b studyDuration of responseIndependent central reviewPrimary study objectiveData monitoring committeeCNS progressionEGFR agentsPo bidBrain metastasesAdult patientsObjective responseOverall survivalCentral reviewStudy treatmentT-DM1CNS therapyTrastuzumab emtansineBenefit rateSelective small molecule inhibitorsBreast carcinomaActive Surveillance in Younger Men With Prostate Cancer
Leapman MS, Cowan JE, Nguyen HG, Shinohara KK, Perez N, Cooperberg MR, Catalona WJ, Carroll PR. Active Surveillance in Younger Men With Prostate Cancer. Journal Of Clinical Oncology 2017, 35: jco.2016.68.005. PMID: 28346806, PMCID: PMC5466007, DOI: 10.1200/jco.2016.68.0058.Peer-Reviewed Original ResearchConceptsBiopsy-based Gleason scoreActive surveillanceAssociation of ageProstate cancerDefinitive treatmentRadical prostatectomyYounger patientsGleason scoreMultivariable Cox proportional hazards regressionYounger ageLow-risk prostate cancerCox proportional hazards regressionGleason score upgradeInitial active surveillanceRelated end pointsCox regression analysisKaplan-Meier methodYounger patient ageProportional hazards regressionPrimary study objectiveInitial biopsyMedian agePatient ageHazards regressionBiochemical outcomes
2014
Intervention design for increasing fruits and veggies among low‐income pregnant Latinas (624.12)
Hromi‐Fiedler A, Chapman D, Segura‐Pérez S, Damio G, Bermúdez‐Millán A, Clark P, Pérez‐Escamilla R. Intervention design for increasing fruits and veggies among low‐income pregnant Latinas (624.12). The FASEB Journal 2014, 28 DOI: 10.1096/fasebj.28.1_supplement.624.12.Peer-Reviewed Original ResearchLow-income pregnant LatinasPregnant LatinasIntervention componentsNutrition education sessionsPrimary study objectiveIntervention designCommunity health educatorsKey intervention componentsCare staff membersEating patternsGroup educationEducation sessionsAppropriate interventionsHealth educatorsLatter groupIntervention successStudy objectiveStaff participantsGroup discussionsTeachable momentGrant funding sourcesPreliminary findingsSocial-ecological frameworkIndividual educationFocus groups
2013
A phase I, first-in-human study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMGN853 in patients (Pts) with epithelial ovarian cancer (EOC) and other FOLR1-positive solid tumors.
Kurkjian C, LoRusso P, Sankhala K, Birrer M, Kirby M, Ladd S, Hawes S, Running K, O'Leary J, Moore K. A phase I, first-in-human study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMGN853 in patients (Pts) with epithelial ovarian cancer (EOC) and other FOLR1-positive solid tumors. Journal Of Clinical Oncology 2013, 31: 2573-2573. DOI: 10.1200/jco.2013.31.15_suppl.2573.Peer-Reviewed Original ResearchNon-small cell lung cancerEpithelial ovarian cancerStudy drug-related serious adverse eventsAdverse eventsEndometrial cancerDose escalationDose levelsSolid tumorsAntibody-drug conjugatesRefractory non-small cell lung cancerDrug-related serious adverse eventsRefractory epithelial ovarian cancerResistant epithelial ovarian cancerClear cell renal cell cancerSerous epithelial ovarian cancerFLT-PET imagingPhase 2 doseSerious adverse eventsRefractory solid tumorsAccelerated titration designCell lung cancerRenal cell cancerPrimary study objectiveEvaluation of safetyGCIG criteria
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