Study study type
PathologyT1T0Patientssample sizesROB Results

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)
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 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)
versus Standard of Care (SoC)
nivolumab alone
CheckMate 037, 2015
  NCT01721746		RCTmML - L2 - all populationnivolumabchemotherapy (investigator’s choice)patients with advanced melanoma (unresectable stage IIIC or IV metastatic melanoma, who progressed after ipilimumab, or ipilimumab and a BRAF inhibitor if they were BRAFV mutation-positive (second-line or later-line treatment).272 / 133high
 inconclusive
  • inconclusive 5 % decrease in deaths (OS) (PE)
  • suggested 2.4-fold increase in objective responses (ORR) (PE)
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)

 

- About us - Contact us - Method - RSS Made with in Lyon - Credits - Privacy policy - Licence Creative Commons