KEYNOTE-045, 2017 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

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 sizes	270 / 272

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

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

KEYNOTE-045, 2017 trial summary PDF trial summary