Study study type PathologyT1T0Patientssample sizesROB Results

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

versus interferon alpha
Ipilimumab (10 mg/kg)
E1609 (ipi10), 2020
  NCT01274338
RCTmML - NA - all populationipilimumab 10 mg/kgHDI high dose of interferon alphamelanoma of cutaneous or unknown primary origin (AJCC 7th edition stage IIIB, IIIC, or IV [M1a or M1b]) who were rendered disease free surgically. No priorsystemic adjuvant therapy was permitted.511 / 636high
inconclusive
  • inconclusive 12 % decrease in deaths (OS) (PE)
  • inconclusive 16 % decrease in RFS/DFS (PE)
ipilimumab alone
E1609 (ipi3), 2020
  NCT01274338
RCTmML - NA - all populationipilimumab 3 mg/kgHDI high dose of interferon alphamelanoma of cutaneous or unknown primary origin (AJCC 7th edition stage IIIB, IIIC, or IV [M1a or M1b]) who were rendered disease free surgically. No priorsystemic adjuvant therapy was permitted.523 / 636high
conclusif
  • demonstrated 22 % decrease in deaths (OS) (PE)
  • inconclusive 15 % decrease in RFS/DFS (PE)
versus placebo
Ipilimumab (10 mg/kg)
EORTC 18071, 2015
  NCT00636168
RCTmML - NA - all populationipilimumab placebo patients with completely resected high-risk stage III melanoma who had not received previous systemic therapy for melanoma475 / 476low
conclusif
  • demonstrated 28 % decrease in deaths (OS) (PE)
  • demonstrated 25 % decrease in RFS/DFS (PE)
  • demonstrated 24 % decrease in MFS (PE)
  • suggested 27 % decrease in deaths (OS) (extension)
  • more...

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

versus Standard of Care (SoC)
tremelimumab
A3671009, 2013
  NCT00257205
RCTmML - L1 - all populationtremelimumabphysician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine)patients with treatment-naive, unresectable stage IIic or IV melanoma328 / 327some concern
inconclusive
  • inconclusive 12 % decrease in deaths (OS) (PE)
INCONCLUSIVE FOR OS

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

versus gp100
ipilimumab alone
MDX010 Ipi vs gp100, 2010
  NCT00094653
RCTmML - L2 - all populationipilimumabgp100patients with previously treated metastatic melanoma and had received a previous therapeutic regimen137 / 136low
conclusif
  • demonstrated 34 % decrease in deaths (OS) (PE)
ipilimumab plus gp100
MDX010 Ipi plus gp100 vs gp100, 2010
  NCT00094653
RCTmML - L2 - all populationipilimumab plus a gp100 peptide vaccinegp100patients with previously treated metastatic melanoma and had received a previous therapeutic regimen403 / 136low
conclusif
  • demonstrated 32 % decrease in deaths (OS) (PE)
versus ipilimumab alone
Ipilimumab (10 mg/kg)
Ascierto (ipi 10 vs 3 mg/kg), 2017
  NCT01515189
RCTmML - L2 - all populationipilimumab 10 mgIpilimumab 3 mgPatients with untreated or previously treated unresectable stage III or IV melanoma, without previous treatment with BRAF inhibitors or immune checkpoint inhibitors,365 / 362low
conclusif
  • demonstrated 16 % decrease in deaths (OS) (PE)
ipilimumab plus gp100
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010
  NCT00094653
RCTmML - L2 - all populationipilimumab plus gp100Ipilimumabpatients with previously treated metastatic melanoma and had received a previous therapeutic regimen403 / 137low
inconclusive
  • statistically significant 51 % decrease in objective responses (ORR)
versus placebo plus SoC
ipilimumab plus SoC
CA184-024, 2011
  NCT00324155
RCTmML - L2 - all populationipilimumab plus dacarbazinedacarbazine plus placebopatients with previously untreated metastatic melanoma, (stage III (unresectable) or stage IV melanoma) with measurable lesions; all patients received dacarbazine.250 / 252low
conclusif
  • demonstrated 28 % decrease in deaths (OS) (PE)
  • demonstrated 24 % decrease in progression or deaths (PFS) (PE)
  • suggested 31 % decrease in deaths (OS) (extension)