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
2000
A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma
Small E, Figlin R, Petrylak D, Vaughn D, Sartor O, Horak I, Pincus R, Kremer A, Bowden C. A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma. Investigational New Drugs 2000, 18: 193-198. PMID: 10857997, DOI: 10.1023/a:1006386115312.Peer-Reviewed Original ResearchConceptsRenal cell carcinomaMetastatic renal cell carcinomaCell carcinomaOpen-label phase II trialCommon drug-related toxicitiesAdvanced renal cell carcinomaPhase II pilot studyNon-hematologic toxicitiesPhase II trialDrug-related toxicityPredictable safety profileReversible myelosuppressionII trialObjective responseSafety profileDisease progressionModerate fatigueWeek 6PatientsSignificant toxicityCarcinomaPilot studyAntitumor potencyWater-soluble analogueCycle 1