Study study type PathologyT1T0Patientssample sizesROB Results

mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive

versus placebo
pembrolizumab alone
KEYNOTE 054 (PDL1>1%), 2018
  NCT02362594
RCTmML - NA - PDL1 positivepembrolizumabplacebopatients with complete Resection of High-Risk Stage III Melanoma, stage IIIA, IIIB or IIIC melanoma with no in-transit metastases, with PDL1 positive status428 / 425low
conclusif
  • demonstrated 46 % decrease in RFS/DFS (PE)
  • suggested 43 % decrease in RFS (extension)
  • demonstrated 40 % decrease in DMFS (PE)