KEYNOTE-045, 2017 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of pembrolizumab versus chemotherapy in patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy

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NCT02256436    N Engl J Med 2017 Feb 17;:  
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Studied treatment pembrolizumab
Control treatment investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine



Patients patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy
Group sizes270 / 272



Blindness open-label Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint OS Design Parallel groups
HypotheseSuperiority



EndpointX1N1X0N0TE95% CI ORR - 270 - 272 no data OS - 270 - 272 0,73[0,59; 0,91] CR - 270 - 272 no data PFS - 270 - 272 0,98[0,81; 1,19]0,22,01,0

Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Poehlein CH, Perini RF, Bajorin DF Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med 2017 Feb 17;:     [PMID: 28212060]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT02256436



Registering number NCT02256436 (see trial on clinicaltrials.gov)
Code Name