melanoma clinical trials results

encorafenib plus binimetinib versus vemurafenib
COLUMBUS, 2018
NCT01909453
oral encorafenib 450 mg once daily plus oral binimetinib 45 mg twice daily
versus
oral vemurafenib 960 mg twice daily
patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutationopen label
Follow-up duration: 16.6 mo (median)
28 countries
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 (Eggermont), 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 + dacarbazine versus dacarbazine
Robert, 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 067 (nivo vs ipi), 2015
NCT01844505
3 mg of nivolumab per kilogram of body weight every 2 weeks
versus
3 mg of ipilimumab per kilogram every 3 weeks for 4 doses
Previously Untreated Advanced Melanoma double-blind
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 Melanomadouble-blind
US
nivolumab + ipilimumab versus ipilimumab
CheckMate 067 (nivo + ipi vs ipi), 2015
NCT01844505
1mg of nivolumab per kilogram every 3 weeks plus 3 mg of ipilimumab per kilogram every 3 weeks for 4 doses, followed by 3 mg of nivolumab per kilogram every 2 weeks for cycle 3 and beyond
versus
3 mg of ipilimumab per kilogram every 3 weeks for 4 doses
Previously Untreated Advanced Melanomadouble-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 versus placebo
KEYNOTE-054, 2018
NCT02362594
Pembrolizumab (Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year)
versus
placebo
patients with complete Resection of High-Risk Stage III Melanomadouble-blind
Follow-up duration: 15 months (median)
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 versus temozolomide
Kirkwood, 2012

versus
Kirkwood,

versus
trametinib and dabrafenib versus dabrafenib
Flaherty, 2012
NCT01072175
dabrafenib (150 mg) plus trametinib (1 or 2 mg)
versus
dabrafenib monotherapy
patients with metastatic melanoma and BRAF V600 mutations
COMBI-D (Long), 2014
NCT01584648
dabrafenib and trametinib
versus
dabrafenib monotherapy
previously untreated patients who had unresectable stage IIIC or stage IV melanoma with a BRAF V600E or V600K mutation
trametinib and dabrafenib versus placebo
COMBI-AD, 2017
NCT01682083
dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months
versus
placebo
Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanomadouble-blind
trametinib and dabrafenib versus vemurafenib
COMBI-V (Robert), 2015
NCT01597908

versus
patients with metastatic melanoma with a BRAF V600 mutation
vemurafenib and cobimetinib versus vemurafenib
Larkin, 2014
NCT01689519
vemurafenib and cobimetinib
versus
vemurafenib and placebo
patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma