2020
A phase III, randomized, open-label study of first-line durvalumab (D) with or without tremelimumab (T) vs standard of care chemotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE)
Powles T, van der Heijden M, Gauna D, Loriot Y, Galsky M, Petrylak D, Ogawa O, Park S, Necchi A, Lee J, De Giorgi U, Bögemann M, Bamias A, Fay A, Duran I, Angra N, Gupta A, He P, Levin W, Bellmunt J. A phase III, randomized, open-label study of first-line durvalumab (D) with or without tremelimumab (T) vs standard of care chemotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE). Annals Of Oncology 2020, 31: s550-s551. DOI: 10.1016/j.annonc.2020.08.769.Peer-Reviewed Original ResearchFORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression.
Quinn D, Petrylak D, Bellmunt J, Necchi A, Gurney H, Lee J, Van Der Heijden M, Rosenbaum E, Penel N, Pang S, Li J, Garcia del Muro X, Joly F, Papai Z, Ellinghaus P, Lu C, Nakajima K, Ishida T, Nishiyama H, Sternberg C. FORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression. Journal Of Clinical Oncology 2020, 38: 489-489. DOI: 10.1200/jco.2020.38.6_suppl.489.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaUrothelial carcinomaPhase II/III studyMedian progression-free survivalTreatment-emergent adverse eventsMuscle-invasive urothelial carcinomaPhase II/IIIDisease control rateOpen-label studyProgression-free survivalStage IV diseaseAcceptable safety profileUrinary tract infectionDNA alterationsStage IIIBIII studyPrior immunotherapyStandard chemotherapyTract infectionsAdverse eventsMedian agePlatinum chemotherapySafety profileControl rateSubgroup analysis
2019
LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy
Tagawa S, Balar A, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hong Q, Gladden A, Kanwal C, Siemon-Hryczyk P, Goswami T, Itri L, Loriot Y. LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy. Annals Of Oncology 2019, 30: v890-v891. DOI: 10.1093/annonc/mdz394.049.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based regimensBristol-Myers SquibbSacituzumab govitecanCheckpoint inhibitorsTrial conductionScientific Advisory BoardSeattle GeneticsBavarian NordicEMD SeronoCohort 1Phase II open-label studyPhase I/II studyECOG performance status 0Boehringer IngelheimPre-planned interim analysisHigh unmet medical needClovis OncologyTreatment-related AEsAntitumor activityOpen-label studyPerformance status 0Significant clinical activitySingle-agent chemotherapyTreatment-related deathsTROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy.
Tagawa S, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hernandez C, Siemon-Hryczyk P, Goswami T, Loriot Y. TROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy. Journal Of Clinical Oncology 2019, 37: tps3153-tps3153. DOI: 10.1200/jco.2019.37.15_suppl.tps3153.Peer-Reviewed Original ResearchObjective response rateAdvanced urothelial cancerProgression-free survivalCheckpoint inhibitor therapyPhase 2 trialSacituzumab govitecanUrothelial cancerEvaluable ptsAdverse eventsInhibitor therapyEastern Cooperative Oncology Group performance status scorePhase II open-label studyTrop-2Median progression-free survivalNeutropenia/neutrophil countEpithelial cell surface antigenOpen-label studyPerformance status scorePhase 1/2 trialPlatinum-based chemotherapyActive metabolite SN38Cell surface antigensFebrile neutropeniaMeasurable diseasePivotal cohortTROPHY-u-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy.
Tagawa S, Petrylak D, Grivas P, Agarwal N, Sternberg C, Siemon-Hryczyk P, Goswam T, Loriot Y. TROPHY-u-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy. Journal Of Clinical Oncology 2019, 37: tps495-tps495. DOI: 10.1200/jco.2019.37.7_suppl.tps495.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerPlatinum-based chemotherapyCheckpoint inhibitor therapyPhase 2 trialSacituzumab govitecanAdverse eventsInhibitor therapyUrothelial cancerPhase II open-label studyTrop-2Median progression-free survivalAdvanced urothelial cancerEpithelial cell surface antigenMedian overall survivalOpen-label studySafety/tolerabilityProgression-free survivalSingle-arm trialCell surface antigensAdvanced UCEvaluable ptsPrior therapyRECIST 1.1Overall survival
2017
Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC).
Bajorin D, De Wit R, Vaughn D, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Puhlmann M, Perini R, Bellmunt J. Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC). Journal Of Clinical Oncology 2017, 35: 4501-4501. DOI: 10.1200/jco.2017.35.15_suppl.4501.Peer-Reviewed Original ResearchAdvanced urothelial cancerUrothelial cancerSurvival analysisPrimary efficacy end pointEnd pointECOG PS 0Efficacy end pointSecond-line chemotherapyTreatment-related AEsOpen-label studySecondary end pointsPD-L1 expressionSuperior safety profileECOG PSKEYNOTE-045Measurable diseaseOS benefitMedian OSPrior therapyBaseline characteristicsLonger OSMedian durationPS 0Systemic therapyLiver metastases
2015
Immune response from STRIDE, a randomized, Phase II, open-label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC)
Drake C, Quinn D, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Campogan D, Fan L, Chang N, Sheikh N, Petrylak D. Immune response from STRIDE, a randomized, Phase II, open-label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC). Journal For ImmunoTherapy Of Cancer 2015, 3: p145. PMCID: PMC4645289, DOI: 10.1186/2051-1426-3-s2-p145.Peer-Reviewed Original Research2526 Immune responses and clinical data from STRIDE, a randomized, phase 2, open label study of sipuleucel-T with concurrent vs sequential enzalutamide administration in metastatic castrationresistant prostate cancer
Petrylak D, Quinn D, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Chang N, DeVries T, Sheikh N, Drake C. 2526 Immune responses and clinical data from STRIDE, a randomized, phase 2, open label study of sipuleucel-T with concurrent vs sequential enzalutamide administration in metastatic castrationresistant prostate cancer. European Journal Of Cancer 2015, 51: s483. DOI: 10.1016/s0959-8049(16)31345-4.Peer-Reviewed Original ResearchImmune response from STRIDE, a randomized, phase 2, open label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC).
Quinn D, Drake C, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Chang N, DeVries T, Sheikh N, Petrylak D. Immune response from STRIDE, a randomized, phase 2, open label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2015, 33: 5040-5040. DOI: 10.1200/jco.2015.33.15_suppl.5040.Peer-Reviewed Original Research
2014
A randomized phase II, open-label study of sipuleucel-T with concurrent or sequential enzalutamide in metastatic castration-resistant prostate cancer (mCRPC).
Quinn D, Petrylak D, Pieczonka C, Sandler A, DeVries T, Sheikh N, Drake C. A randomized phase II, open-label study of sipuleucel-T with concurrent or sequential enzalutamide in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: e16071-e16071. DOI: 10.1200/jco.2014.32.15_suppl.e16071.Peer-Reviewed Original Research
2012
943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC)
Corman J, Dawson N, Hall S, Nabhan C, Ferrari A, Armstrong A, Murdock M, Stewart F, Sheikh N, Petrylak D. 943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC). Annals Of Oncology 2012, 23: ix311. DOI: 10.1016/s0923-7534(20)33504-3.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerTotal nucleated cell countImmune responseHigher baseline prostate-specific antigenPhase 2 open-label studyCell countBaseline prostate-specific antigenAntigen-specific immune responsesCastrate-resistant prostate cancerT cell proliferative responsesAutologous cellular immunotherapyCostimulatory molecules CD54Sipuleucel-T treatmentOpen-label studySpeakers bureauHigher total nucleated cell countSanofi-AventisVirginia Mason Medical CenterRisk of deathCell proliferative responsesProstate-specific antigenNucleated cell countD exposureBristol-Myers SquibbCD54 upregulation
2009
A phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer
Petrylak D, Resto-Garces K, Tibyan M, Mohile S. A phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer. Journal Of Clinical Oncology 2009, 27: 5156-5156. DOI: 10.1200/jco.2009.27.15_suppl.5156.Peer-Reviewed Original ResearchMeasurable diseaseDay 1Dose levelsPhase I open-label studyCastration-resistant prostate cancerGrade 3 neutropeniaGrade 3/4 toxicitiesGrade 4 neutropeniaMedian baseline PSAOpen-label studyPost-treatment PSAPrior chemotherapy regimensMetastatic pulmonary nodulesDeep venous thrombosisFurther dose escalationPhase I trialEfficacy of docetaxelNear complete resolutionCycle 1Derivative of thalidomideAntiandrogen withdrawalNCI trialProphylactic anticoagulationTreatment PSAChemotherapy regimens