2020
Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab in locally advanced or metastatic urothelial cancer.
Mar N, Friedlander T, Hoimes C, Flaig T, Bilen M, Balar A, Henry E, Srinivas S, Rosenberg J, Petrylak D, Burgess E, Merchan J, Tagawa S, Carret A, Steinberg J, Chaney M, Milowsky M. Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab in locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2020, 38: tps5092-tps5092. DOI: 10.1200/jco.2020.38.15_suppl.tps5092.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsPlatinum-containing chemotherapyMetastatic urothelial cancerPD-L1 inhibitorsRECIST v1.1Investigator assessmentUrothelial cancerMicrotubule-disrupting agent monomethyl auristatin EDay 1PD-1 inhibitor pembrolizumabActive CNS metastasesCisplatin-containing therapyFirst-line patientsPrior systemic treatmentPD-L1 statusTumor response rateMonomethyl auristatin EAntibody-drug conjugatesMeasurable diseaseCNS metastasisPrimary endpointSecondary endpointsCreatinine clearanceSystemic treatmentUncontrolled diabetes
2007
Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)
Vaughn D, Srinivas S, Stadler W, Pili R, Petrylak D, De Marco S, Smith D, Nason S, De Wit E, George C. Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU). Journal Of Clinical Oncology 2007, 25: 15543-15543. DOI: 10.1200/jco.2007.25.18_suppl.15543.Peer-Reviewed Original ResearchInitial doseResponse rateManageable toxicity profileObjective response ratePlatinum-containing regimenPoor performance statusPrior pelvic irradiationPhase II studySingle-arm studyTransitional cell carcinomaVinca alkaloid classNew microtubule inhibitorMales 78Febrile neutropeniaMeasurable lesionsRenal impairmentCreatinine clearanceEfficacy endpointII studyLast doseMain toxicityPelvic irradiationPerformance statusPeripheral neuropathyCell carcinoma