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 mutation	open label Follow-up duration: 16.6 mo (median) 28 countries
ID IFN alpha-2b (I M) versus observation
EORTC18952 (Eggermont), 2005	versus	patients who had had a thick primary tumour (thickness4 mm) resected (stage IIb) or regional lymph node metastases dissected (stage III)	Follow-up duration: 4.65 years
Nordic IFN Trial, 2011	intermediate-dose interferon alfa-2b duration 1 versus duration 2	patients with stage IIB-IIC or III resected cutaneous melanoma.	Follow-up duration: 72·4 months
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 melanoma	double-blind Follow-up duration: 5.3 years
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 disease	open-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 subgroup IIIB-C,	versus
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 Melanoma	double-blind Follow-up duration: 18 months (median) 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 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
PEG IFN alpha-2b (I M) versus observation
EORTC18991 (Eggermont), 2008	pegylated interferon alfa-2b 6 mug/kg per week for 8 weeks (induction) then 3 mug/kg per week (maintenance) for an intended duration of 5 years versus	patients with resected stage III melanoma	Follow-up duration: 3.8 years
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 Melanoma	double-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 disease	open-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 inhibitor	open 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 doses	open-label
rIFN alpha-2b versus observation
EORTC18871/DKG 80-1 stage III,	versus
EORTC18871/DKG 80-1 (Kleeberg), 2004	rIFN-alpha2b versus observation	High-risk stage II patients (thickness >3 mm) and stage III patients (positivelymph nodes) without distant metastasis	Follow-up duration: 8.2 years (median)
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 melanoma	double-blind
trametinib and dabrafenib versus SOC
COMBI neo, 2018 NCT02231775	versus
trametinib and dabrafenib versus vemurafenib
COMBI-V (Robert), 2015 NCT01597908	versus	patients with metastatic melanoma with a BRAF V600 mutation
vemurafenib versus placebo
BRIM 8, 2018 NCT01667419	e twice-daily adjuvant oral vemurafenib 960 mg tablets for52 weeks (13×28-day cycles) versus placebo	patients with resected,BRAFV600 mutation-positive melanoma: IC–IIIA–IIIB (cohort 1) or stage IIIC (cohort 2)
BRIM 8 (cohort IIIC),	versus
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