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 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...
mML - L1 - all population metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - all population
versus Standard of Care (SoC)
	tremelimumab
	A3671009, 2013 J. Clin. Oncol. 2013; 31:616-22 NCT00257205	RCT	mML - L1 - all population	tremelimumab	physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine)	patients with treatment-naive, unresectable stage IIic or IV melanoma	328 / 327	some concern	inconclusive	inconclusive 12 % decrease in deaths (OS) (PE) INCONCLUSIVE FOR OS
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 N Engl J Med 2010;363:711-23 Ann. Oncol. 2013; 24:2694-8 Clin. Cancer Res. 2013; 19:2232-9 Cancer 2013; 119:1675-82 NCT00094653	RCT	mML - L2 - all population	ipilimumab	gp100	patients with previously treated metastatic melanoma and had received a previous therapeutic regimen	137 / 136	low	conclusif	demonstrated 34 % decrease in deaths (OS) (PE)
	ipilimumab plus gp100
	MDX010 Ipi plus gp100 vs gp100, 2010 N Engl J Med 2010;363:711-23 Ann. Oncol. 2013; 24:2694-8 Clin. Cancer Res. 2013; 19:2232-9 Cancer 2013; 119:1675-82 NCT00094653	RCT	mML - L2 - all population	ipilimumab plus a gp100 peptide vaccine	gp100	patients with previously treated metastatic melanoma and had received a previous therapeutic regimen	403 / 136	low	conclusif	demonstrated 32 % decrease in deaths (OS) (PE)
versus ipilimumab alone
	Ipilimumab (10 mg/kg)
	Ascierto (ipi 10 vs 3 mg/kg), 2017 Lancet Oncol. 2017; 18:611-622 NCT01515189	RCT	mML - L2 - all population	ipilimumab 10 mg	Ipilimumab 3 mg	Patients with untreated or previously treated unresectable stage III or IV melanoma, without previous treatment with BRAF inhibitors or immune checkpoint inhibitors,	365 / 362	low	conclusif	demonstrated 16 % decrease in deaths (OS) (PE)
	ipilimumab plus gp100
	MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 N Engl J Med 2010;363:711-23 Ann. Oncol. 2013; 24:2694-8 Clin. Cancer Res. 2013; 19:2232-9 Cancer 2013; 119:1675-82 NCT00094653	RCT	mML - L2 - all population	ipilimumab plus gp100	Ipilimumab	patients with previously treated metastatic melanoma and had received a previous therapeutic regimen	403 / 137	low	inconclusive	statistically significant 51 % decrease in objective responses (ORR)
versus placebo plus SoC
	ipilimumab plus SoC
	CA184-024, 2011 N Engl J Med 2011;364:2517-26 J Clin Oncol 2015;33:1191-6 NCT00324155	RCT	mML - L2 - all population	ipilimumab plus dacarbazine	dacarbazine plus placebo	patients with previously untreated metastatic melanoma, (stage III (unresectable) or stage IV melanoma) with measurable lesions; all patients received dacarbazine.	250 / 252	low	conclusif	demonstrated 28 % decrease in deaths (OS) (PE) demonstrated 24 % decrease in progression or deaths (PFS) (PE) suggested 31 % decrease in deaths (OS) (extension)

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

mML - L1 - all population metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - all population

mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population