Study study type PathologyT1T0Patientssample sizesROB Results

mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-045 (all population), 2017
  NCT02256436
RCTmUC - L2 - all populationpembrolizumabchemotherapy (ICC) : paclitaxel, docetaxel, or vinfluninepatients with advanced urothelial carcinoma that progressed during or after the receipt of platinumbased chemotherapy treated as second-line therapy270 / 272some concern
conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
  • inconclusive 2 % decrease in progression or deaths (PFS) (PE)
  • suggested 30 % decrease in deaths (OS) (extension)
  • demonstrated 1.1-fold increase in objective responses (ORR) (PE)
  • more...