metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	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 J Clin Oncol 2020; 38:567-575 NCT01274338	RCT	mML - NA - all population	ipilimumab 10 mg/kg	HDI high dose of interferon alpha	melanoma 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 / 636	high	inconclusive	inconclusive 12 % decrease in deaths (OS) (PE) inconclusive 16 % decrease in RFS/DFS (PE)
	ipilimumab alone
	E1609 (ipi3), 2020 J Clin Oncol 2020; 38:567-575 NCT01274338	RCT	mML - NA - all population	ipilimumab 3 mg/kg	HDI high dose of interferon alpha	melanoma 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 / 636	high	conclusif	demonstrated 22 % decrease in deaths (OS) (PE) inconclusive 15 % decrease in RFS/DFS (PE)
versus Ipilimumab (10 mg/kg)
	nivolumab alone
	CheckMate 238, 2017 N Engl J Med 2017;377:1824-1835 Journal of Dermatology 2019; 46:1197-. Lancet Oncol 2020 Sep 18;S1470-2045(20)30494-0. NCT02388906	RCT	mML - NA - all population	nivolumab	ipilimumab	patient, 15 years of age or older, with high-risk resected stage IIIB, IIIC, or IV melanoma as adjuvant treatment	453 / 453	low	conclusif	demonstrated 35 % decrease in RFS/DFS (PE) suggested 27 % decrease in MFS suggested 29 % decrease in RFS (extension)
versus nivolumab alone
	nivolumab plus ipilimumab
	IMMUNED (NI vs N) EXPLORATORY, 2020 Lancet 2020; 395:1558-1568 NCT02523313	RCT	mML - NA - all population	nivolumab plus ipilimumab	nivolumab	adjuvant therapy with nivolumab alone or in combination with ipilimumab compared with placebo in patients with stage IV melanoma with no evidence of disease	56 / 59	low	inconclusive	suggested 60 % decrease in RFS/DFS
versus placebo
	Ipilimumab (10 mg/kg)
	EORTC 18071, 2015 N. Engl. J. Med. 2016; 375:1845-1855 Lancet Oncol. 2017; 18:393-403 Eur. J. Cancer 2019; 119:1-10 Lancet Oncol. 2015; 16:522-30 NCT00636168	RCT	mML - NA - all population	ipilimumab	placebo	patients with completely resected high-risk stage III melanoma who had not received previous systemic therapy for melanoma	475 / 476	low	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...
	nivolumab alone
	IMMUNED (N vs P ; all population), 2020 Lancet 2020; 395:1558-1568 NCT02523313	RCT	mML - NA - all population	nivolumab	placebo	adjuvant therapy with nivolumab alone or in combination with ipilimumab compared with placebo in patients with stage IV melanoma with no evidence of disease	59 / 52	low	conclusif	demonstrated 44 % decrease in RFS/DFS (PE)
	nivolumab plus ipilimumab
	IMMUNED (NI vs P ; all population), 2020 Lancet 2020; 395:1558-1568 NCT02523313	RCT	mML - NA - all population	nivolumab plus ipilimumab	placebo	adjuvant therapy with nivolumab alone or in combination with ipilimumab compared with placebo in patients with stage IV melanoma with no evidence of disease	56 / 52	low	conclusif	demonstrated 77 % decrease in RFS/DFS (PE)
	pembrolizumab alone
	KEYNOTE 054 (all population), 2018 N. Engl. J. Med. 2018; 378:1789-1801 JAMA Oncol 2020; : European Journal of Cancer 2019; 116:148-. J Clin Oncol 2020 Sep 18;JCO2002110. J Med Econ 2019 Oct;22(10):981-993. JAMA Oncol 2020; 6:519-527 Lancet Oncol 2021 Apr 12;S1470-2045(21)00065-6. Lancet Oncol 2021 Apr 12;S1470-2045(21)00081-4. NEJM Evidence NCT02362594	RCT	mML - NA - all population	pembrolizumab	placebo	patients with complete Resection of High-Risk Stage III Melanoma, stage IIIA, IIIB or IIIC melanoma with no in-transit metastases,	514 / 505	low	conclusif	demonstrated 43 % decrease in RFS/DFS (PE) suggested 47 % decrease in MFS suggested 44 % decrease in RFS (extension) suggested 41 % decrease in RFS (extension) more...
mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive
versus placebo
	pembrolizumab alone
	KEYNOTE 054 (PDL1>1%), 2018 N. Engl. J. Med. 2018; 378:1789-1801 JAMA Oncol 2020; : European Journal of Cancer 2019; 116:148-. J Clin Oncol 2020 Sep 18;JCO2002110. J Clin Oncol 2020 Nov 20;38(33):3925-3936. J Med Econ 2019 Oct;22(10):981-993. Lancet Oncol 2021 Apr 12;S1470-2045(21)00065-6. Lancet Oncol 2021 Apr 12;S1470-2045(21)00081-4. NCT02362594	RCT	mML - NA - PDL1 positive	pembrolizumab	placebo	patients with complete Resection of High-Risk Stage III Melanoma, stage IIIA, IIIB or IIIC melanoma with no in-transit metastases, with PDL1 positive status	428 / 425	low	conclusif	demonstrated 46 % decrease in RFS/DFS (PE) suggested 43 % decrease in RFS (extension) demonstrated 40 % decrease in DMFS (PE)

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

mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive