Study study type PathologyT1T0Patientssample sizesROB Results

mML - L1 - all population metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - all population

versus ipilimumab alone
nivolumab plus ipilimumab
CheckMate 067 (NI vs I ; all population), 2015
  NCT01844505
RCTmML - L1 - all populationnivolumab plus ipilimumabipilimumabpatients with previously untreated, unresectable or metastatic histologically confirmed stage III or IV melanoma.314 / 315low
conclusif
  • demonstrated 45 % decrease in deaths (OS) (PE)
  • demonstrated 58 % decrease in progression or deaths (PFS) (PE)
  • suggested 48 % decrease in deaths (OS) (extension)
  • suggested 58 % decrease in PFS (extension)
  • more...
CheckMate 069 (all population), 2015
  NCT01927419
RCTmML - L1 - all populationnivolumab and ipilimumabipilimumabunresectable, previously untreated stage III or IV melanoma with measurable disease, with BRAF Wild-Type Tumors and BRAF mutant95 / 47low
conclusif
  • demonstrated 62 % decrease in progression or deaths (PFS) (PE)
  • suggested 64 % decrease in PFS (extension)
  • demonstrated 14.1-fold increase in objective responses (ORR) (PE)
versus nivolumab alone
nivolumab plus ipilimumab
CheckMate 067 (NI vs N) EXPLORATORY, 2015
  NCT01844505
RCTmML - L1 - all populationnivolumab plus ipilimumabnivolumabpatients with previously untreated, unresectable or metastatic histologically confirmed stage III or IV melanoma.314 / 316low
inconclusive
  • suggested 35 % decrease in deaths (OS)
  • suggested 21 % decrease in PFS (extension)
  • suggested 26 % decrease in progression or deaths (PFS)

mML - L1 - BRAF mutant metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF mutant

versus ipilimumab alone
nivolumab plus ipilimumab
CheckMate 069 (BRAF mutant) EXPLORATORY, 2015
  NCT01927419
RCTmML - L1 - BRAF mutantnivolumab and ipilimumabipilimumab unresectable, previously untreated stage III or IV melanoma with measurable disease, with BRAF mutant Tumors23 / 10low
inconclusive
    no statistically significant result

mML - L1 - BRAF wild metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF wild

versus ipilimumab alone
nivolumab plus ipilimumab
CheckMate 069 (BRAF wild type), 2015
  NCT01927419
RCTmML - L1 - BRAF wildnivolumab and ipilimumabipilimumab unresectable, previously untreated stage III or IV melanoma with measurable disease, with BRAF Wild-Type Tumors72 / 37low
conclusif
  • demonstrated 60 % decrease in progression or deaths (PFS) (PE)
  • demonstrated 12.0-fold increase in objective responses (ORR) (PE)