2022
Randomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011).
Sonpavde G, Plets M, Liss M, Meeks J, Petrylak D, Cole S, McKay R, Gupta S, Hita S, Pereira T, Bangs R, Tangen C, Thompson I, Lerner S. Randomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011). Journal Of Clinical Oncology 2022, 40: tps591-tps591. DOI: 10.1200/jco.2022.40.6_suppl.tps591.Peer-Reviewed Original ResearchMuscle-invasive urothelial carcinomaMuscle-invasive bladder cancerUpper tract urothelial carcinomaImmune checkpoint inhibitorsWeeks x 4 cyclesPathologic complete remissionEvent-free survivalPhase II trialUpfront surgeryUrothelial carcinomaDay 1II trialNeoadjuvant therapyOverall survivalHigh-risk upper tract urothelial carcinomaCisplatin-ineligible metastatic urothelial carcinomaNeoadjuvant cisplatin-based combination chemotherapyOpen-label phase II trialHigh grade upper tract urothelial carcinomaNeoadjuvant immune checkpoint inhibitorsRandomized phase II trialCisplatin-based combination chemotherapyCisplatin-eligible patientsMetastatic urothelial carcinomaPD-L1 inhibitors
2020
Study EV-103: New cohorts testing enfortumab vedotin alone or in combination with pembrolizumab in muscle invasive urothelial cancer.
Hoimes C, Rosenberg J, Petrylak D, Carret A, Sasse C, Chaney M, Flaig T. Study EV-103: New cohorts testing enfortumab vedotin alone or in combination with pembrolizumab in muscle invasive urothelial cancer. Journal Of Clinical Oncology 2020, 38: tps595-tps595. DOI: 10.1200/jco.2020.38.6_suppl.tps595.Peer-Reviewed Original ResearchMuscle-invasive urothelial cancerInvasive urothelial cancerRadical cystectomyPathology reviewUrothelial cancerMicrotubule-disrupting agent monomethyl auristatin EDay 1PD-1/PD-L1 inhibitorsResponse rateInvestigational antibody-drug conjugatePathological complete response rateTreatment-related adverse eventsNeoadjuvant cisplatin-based chemotherapyCisplatin-eligible patientsPathological response rateComplete response rateFirst-line settingLymph node dissectionPD-1 inhibitorsCentral pathology reviewDisease-free survivalPhase 2 studyCisplatin-based chemotherapyPD-L1 inhibitorsMonomethyl auristatin E