Study study type PathologyT1T0Patientssample sizesROB Results

mML - NA - all population metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - all population

versus placebo
pembrolizumab alone
KEYNOTE 054 (all population), 2018
  NCT02362594
RCTmML - NA - all populationpembrolizumabplacebopatients with complete Resection of High-Risk Stage III Melanoma, stage IIIA, IIIB or IIIC melanoma with no in-transit metastases,514 / 505low
conclusif
  • demonstrated 43 % decrease in RFS/DFS (PE)
  • suggested 47 % decrease in MFS
  • suggested 44 % decrease in RFS (extension)
  • suggested 41 % decrease in RFS (extension)
  • more...

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)

mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population

versus ipilimumab alone
pembrolizumab (10mg/kg)
KEYNOTE-006 (3 week), 2015
  NCT01866319
RCTmML - L2 - all populationpembrolizumab every 3 wkipilimumabhistologically confirmed, unresectable stage III or IV melanoma and had received no more than one previous systemic therapy for advanced disease277 / 278some concern
conclusif
  • demonstrated 31 % decrease in deaths (OS) (PE)
  • demonstrated 42 % decrease in progression or deaths (PFS) (PE)
  • suggested 32 % decrease in deaths (OS) (extension)
  • suggested 39 % decrease in PFS (extension)
pembrolizumab (10mg/kg) 2 weeks
KEYNOTE-006 (2 week), 2015
  NCT01866319
RCTmML - L2 - all populationpembrolizumab every 2 wkipilimumabhistologically confirmed, unresectable stage III or IV melanoma and had received no more than one previous systemic therapy for advanced disease279 / 278some concern
conclusif
  • demonstrated 37 % decrease in deaths (OS) (PE)
  • demonstrated 42 % decrease in progression or deaths (PFS) (PE)
  • suggested 32 % decrease in deaths (OS) (extension)
  • suggested 39 % decrease in PFS (extension)
versus Standard of Care (SoC)
pembrolizumab (10mg/kg)
KEYNOTE-002 (10 mg/kg), 2015
  NCT01704287
RCTmML - L2 - all populationpembrolizumabICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)18 years or older with unresectable stage III or stage IV melanoma, not amenable to local therapy; confirmed disease progression within 24 weeks of the last ipilimumab dose, previous BRAF or MEK inhibitor therapy or both,181 / 179some concern
conclusif
  • suggested 26 % decrease in deaths (OS) (PE)
  • demonstrated 50 % decrease in progression or deaths (PFS) (PE)
pembrolizumab (2mg/kg)
KEYNOTE-002 (2 mg/kg), 2015
  NCT01704287
RCTmML - L2 - all populationpembrolizumabICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)unresectable stage III or stage IV melanoma not amenable to local therapy; confirmed disease progression14 within 24 weeks of the last ipilimumab dose180 / 179some concern
conclusif
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • demonstrated 43 % decrease in progression or deaths (PFS) (PE)

mML - L2 - BRAF mutant metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - BRAF mutant

versus placebo plus SoC
pembrolizumab plus SoC
KEYNOTE-022, 2019
  NCT02130466
RCTmML - L2 - BRAF mutantpembrolizumab, with dabrafenib and trametinibplacebo with dabrafenib and trametinibpatients with BRAFV600-mutant with advanced unresectable stage III or metastatic stage IV melanoma AND has received prior systemic therapy60 / 60low
inconclusive
  • inconclusive 34 % decrease in progression or deaths (PFS) (PE)