melanoma clinical trials results

biochemotherapy versus chemotherapy
Eton, 2002

versus
Patients with advanced, unresectable nonchoroidal MM with indicator lesions
NR
carboplatin + paclitaxel versus paclitaxel
Zimpfer, 2003

versus
Patients with stage IV melanoma
Germany
dabrafenib + trametinib versus dabrafenib
COMBIE-d,
NCT01584648

versus
dabrafenib and trametinib versus dabrafenib monotherapy
COMBI-D, 0
NCT01584648
dabrafenib and trametinib
versus
dabrafenib monotherapy
Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive will be screened for eligibilitydouble-blind
dabrafenib plus trametinib versus vemurafenib
COMBI-v, 2015
NCT01597908
combination of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily)
versus
vemurafenib (960 mg twice daily)
Unresectable or Metastatic BRAF V600E/K Cutaneous Melanomaopen label
dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine
Chiarion, 2001

versus
Patients with unresectable MM (stage III and IV)
NR
dacarbazine-vindesine versus Dacarbazine
Ringborg, 1989
Dacarbazine 250 mg/m2 days 1–5 q 28 days
versus
Dacarbazine 250 mg/m2 days 1–5 q 28 days; vindesine 3 mg/m2 day 1 q 28 days
ipi + gp100 versus gp100
Hodi (ipi + gp100), 2010
NCT00094653
Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with gp100 every 3 weeks for up to four treatments
versus
gp100 alone
patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease open-label
ipilimumab versus placebo
EORTC 18071, 2015
NCT00636168
ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred
versus
placebo
high risk patients who had undergone complete resection of stage III melanomadouble-blind
ipilimumab 10mg/kg plus dacarbazine versus dacarbazine
Robert (Ipilimumab), 2011
NCT00324155
ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of body-surface area)
versus
dacarbazine (850 mg per square meter)
patients with previously untreated metastatic melanoma (stage III (unresectable) orstage IV)double blind
ipilimumab 3 mg/kg versus gp100
Hodi (ipi alone), 2010
NCT00094653
ipilimumab 3mg/kg every 3 weeks up to 4 treatments
versus
gp100 alone
patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic diseaseopen-label
nivolumab versus chemotherapy
CheckMate 037 (Weber), 2015
NCT01721746
ntravenous infusion of nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxic eff ects
versus
investigator’s choice of chemotherapy (dacarbazine 1000 mg/m² every 3 weeks or paclitaxel 175 mg/m² combined with carboplatin area under the curve 6 every 3 weeks)
patients with advanced melanoma who progressed after ipilimumab, or ipilimumab and a BRAF inhibitor if they were BRAFV mutation-positive (second-line or later-line treatment)open-label
nivolumab versus dacarbazine
CheckMate 066 (Robert), 2015
NCT01721772
nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks
versus
dacarbazine at a dose of 1000 mg per square meter of body-surface area every 3 weeks
previously untreated patients who had unresectable metastatic melanoma without a BRAF mutation (stage III or IV)double-blind
nivolumab versus ipilimumab
CheckMate 238, 2017
NCT02388906
nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks
versus
ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks
patients with Complete Resection of Stage IIIb/c or Stage IV Melanoma double-blind
US
CheckMate 067 (nivo vs ipi), 2015
NCT01844505
nivolumab
versus
Ipilimumab alone
Previously Untreated Advanced Melanoma double-blind
nivolumab + ipilimumab versus ipilimumab
CheckMate 067 (nivo + ipi vs ipi), 2015
NCT01844505
Nivolumab + ipilumab
versus
Ipilimumab alone
Previously Untreated Advanced Melanoma double-blind
Postow, 2015
NCT01927419
nivolumab (1 mg per kilogram)and ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks for four doses followed by nivolumab (3 mg per kilogram) every 2 weeks until the occurrence of disease progression or unacceptable toxic effects
versus
patients with metastatic melanoma who had not previously received treatment,double-blind
nivolumab + ipilimumab versus nivolumab
CheckMate 067 (nivo + ipi vs nivo), 2015
NCT01844505
Nivolumab + ipilumab
versus
nivolumab alone
Previously Untreated Advanced Melanoma double-blind
pembrolizumab (every 2W) versus ipilimumab
KEYNOTE-006 (every 2W), 2015
NCT01866319
pembrolizumab (at a dose of 10 mg per kilogram of body weight) every 2 weeks or every 3 weeks
versus
four doses of ipilimumab (at 3 mg per kilogram) every 3 weeks
patients with advanced melanoma who had received no more than one previous systemic therapy for advanced diseaseopen-label
pembrolizumab (every 3W) versus ipilimumab
KEYNOTE-006 (every 3W), 2015
NCT01866319
Pembrolizumab Every 3 Weeks
versus
Ipilimumab (Participants receive ipilimumab, 3 mg/kg IV, once every 3 weeks for a total oPembrolizumab Every 2 Weeks (Participants receive pembrolizumab, 10 mg intravenously (IV), once every 2 weeks for up to 2 years) 2/ Pembrolizumab Every 3 Weeks (P
patients with unresectable stage III or IV advanced melanoma and who had received no more than one previous systemic therapy for advanced disease open label
pembrolizumab 10mg/kg versus chemotherapy
KEYNOTE 002 (10mg/kg Q3W), 2015
NCT01704287
intravenous pembrolizumab 10 mg/kg every 3 weeks
versus
investigator-choice chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or oral temozolomide)
patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAFV600 mutation positive, a BRAF inhibitor open design
pembrolizumab 2mg/kg versus chemotherapy
KEYNOTE 002 (2mg/kg Q3W), 2015
NCT01704287
Pembrolizumab 2 mg/kg IV Q3W
versus
investigator-choice chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or oral temozolomide)
patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAFV600 mutation positive, a BRAF inhibitoropen design
pembrolizumab 2mg/kg versus pembrolizumab 10mg/kg
KEYNOTE-001, 2014
NCT01295827
intravenous pembrolizumab at 2 mg/kg every 3 weeks
versus
intravenous pembrolizumab at 10 mg/kg every 3 weeks
patients (aged ¡Ý18 years) with advanced melanoma whose disease had progressed after at least two ipilimumab dosesopen-label
Selumetinib +dacarbazine versus placebo plus dacarbazine
Robert, 2013

versus
trametinib and dabrafenib versus dabrafenib
Long, 2014
NCT01584648
dabrafenib (150 mg orally twice daily) and trametinib (2 mg orally once daily)
versus
dabrafenib and placebo
previously untreated patients who had unresectable stage IIIC or stage IV melanoma with a BRAF V600E or V600K mutation
Flaherty, 2012
NCT01072175
dabrafenib (150 mg) plus trametinib (1 or 2 mg)
versus
dabrafenib monotherapy
patients with metastatic melanoma and BRAF V600 mutations
vinblastine, bleomycin,cisplatinum versus dacarbazine
Luikart, 1984

versus
Patients with stage III metastatic malignant melanoma
USA