2024
A phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2.
Loriot Y, Siefker-Radtke A, Friedlander T, Necchi A, Wei A, Sridhar S, Garmezy B, Arroyo S, Gartside E, Liu J, Campbell C, Bader J, Petrylak D. A phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2. Journal Of Clinical Oncology 2024, 42: tps4619-tps4619. DOI: 10.1200/jco.2024.42.16_suppl.tps4619.Peer-Reviewed Original ResearchUrothelial cancerMonomethyl auristatin ECohort 2Cohort 1Nectin-4Optimal doseExposure to normal tissuesInterim analysisBlinded independent central reviewMetastatic urothelial cancerObjective response ratePenetrate solid tumorsAdequate organ functionDisease control rateProgression-free survivalPlatinum-based chemotherapyDuration of responseECOG performance statusPreliminary antitumor activityIndependent central reviewPlasma half-lifeWeeks follow-upMetastatic UCRECIST v1.1Enfortumab vedotin
2020
Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921.
Petrylak D, Shore N, Bennamoun M, Ratta R, Piulats J, Li B, Schloss C, Fizazi K. Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921. Journal Of Clinical Oncology 2020, 38: tps262-tps262. DOI: 10.1200/jco.2020.38.6_suppl.tps262.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneRECIST v1.1Prostate Cancer Working Group 3Castration-resistant prostate cancerEnd pointAdequate organ functionECOG PS 0Months of screeningPSA response rateSubsequent anticancer therapyAndrogen deprivation therapyPD-1 inhibitorsPrimary end pointSecondary end pointsSingle-agent antitumor activityPhase 3 trialPhase III studyDeprivation therapyPSA progressionUnacceptable toxicityAbiraterone acetateIII studyMetastasis locationPS 0
2019
891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Petrylak D, Li B, Schloss C, Fizazi K. 891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v351. DOI: 10.1093/annonc/mdz248.048.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneAndrogen deprivation therapySubsidiary of MerckDohme Corp.Merck SharpKey secondary efficacy end pointsRadiographic progression-free survivalRandomized phase 3 trialSecondary efficacy end pointsCastration-resistant prostate cancerAdequate organ functionECOG PS 0/1Subsequent anticancer therapyEfficacy end pointPhase 3 trialProgression-free survivalRadiographic disease progressionCT/MRIBristol-Myers SquibbAdult ptsDeprivation therapyPS 0/1RECIST v1.1Unacceptable toxicity
2013
Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC).
Tannock I, Fizazi K, Ivanov S, Thellenberg-Karlsson C, Flechon A, Skoneczna I, Orlandi F, Gravis G, Matveev V, Bavbek S, Gil T, Viana L, Aren O, Karyakin O, Elliott T, Birtle A, Magherini E, Petrylak D, Tombal B, Rosenthal M. Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2013, 31: 5002-5002. DOI: 10.1200/jco.2013.31.15_suppl.5002.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDocetaxel/prednisoneFirst-line chemotherapyAflibercept armPlacebo armHazard ratioMedian relative dose intensityRecombinant human fusion proteinStandard first-line chemotherapyCastration-resistant prostate cancerGrowth factorAdequate organ functionCycles of therapyPSA response rateRelative dose intensityFatal adverse eventsProgression-free survivalVascular endothelial growth factorClinical trial informationEndothelial growth factorHuman fusion proteinTrial-specific modulesOral prednisonePrimary endpointPrior chemotherapy
2012
Randomized phase II trial of maintenance sunitinib versus placebo following response to chemotherapy (CT) for patients (pts) with advanced urothelial carcinoma (UC).
Grivas P, Nanus D, Stadler W, Daignault S, Dreicer R, Kohli M, Petrylak D, Vaughn D, Bylow K, Belldegrun A, Sottnik J, Keller E, Smith D, Hussain M. Randomized phase II trial of maintenance sunitinib versus placebo following response to chemotherapy (CT) for patients (pts) with advanced urothelial carcinoma (UC). Journal Of Clinical Oncology 2012, 30: 265-265. DOI: 10.1200/jco.2012.30.5_suppl.265.Peer-Reviewed Original ResearchOpen-label sunitinibAdvanced urothelial carcinomaUrothelial carcinomaMaintenance sunitinibProgression rateResponse rateMedian age 69 yearsRandomized phase II trialAdequate organ functionECOG PS 0ECOG PS 1Objective response rateCycles of chemotherapyVEGF/Age 69 yearsPhase II trialSerum level changesProgression of UCMedian TTPSecondary endpointsStable diseaseII trialOral sunitinibPS 0Complete response
2006
Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report
Smith D, Mackler N, Hussain M, Dunn R, Montie J, Wood D, Lee C, Petrylak D, Quinn D, Vaishampayan U. Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report. Journal Of Clinical Oncology 2006, 24: 4541-4541. DOI: 10.1200/jco.2006.24.18_suppl.4541.Peer-Reviewed Original ResearchTransitional cell carcinomaAdvanced transitional cell carcinomaPT0 rateArm IArm IITreatment of TCCGrade 3/4 hematologic toxicitiesM0 transitional cell carcinomaAdequate organ functionCycles of therapyGrade 3 toxicityPerformance status 0Pathologic complete respondersNational Cancer InstituteBristol-Myers SquibbNeoadjuvant paclitaxelStatus 0Complete respondersEvaluable subjectsHematologic toxicityNeoadjuvant chemotherapyPrimary endpointPositive patientsResection rateClinical T3