metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
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)
	pembrolizumab (10mg/kg)
	KEYNOTE-006 (3 week), 2015 Lancet 2017;390:1853-1862 N Engl J Med 2015;372:2521-32 Lancet Oncol. 2019; 20:1239-1251 Eur. J. Cancer 2018; 101:236-243 Eur. J. Cancer 2017; 86:115-124 Eur J Cancer 2020 Dec 23;144:182-191. NCT01866319	RCT	mML - L2 - all population	pembrolizumab every 3 wk	ipilimumab	histologically confirmed, unresectable stage III or IV melanoma and had received no more than one previous systemic therapy for advanced disease	277 / 278	some concern	conclusif	demonstrated 31 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in progression or deaths (PFS) (PE) suggested 32 % decrease in deaths (OS) (extension) suggested 39 % decrease in PFS (extension)
	pembrolizumab (10mg/kg) 2 weeks
	KEYNOTE-006 (2 week), 2015 Lancet 2017;390:1853-1862 N Engl J Med 2015;372:2521-32 Eur. J. Cancer 2018; 101:236-243 Lancet Oncol. 2019; 20:1239-1251 Eur. J. Cancer 2017; 86:115-124 Eur J Cancer 2020 Dec 23;144:182-191. NCT01866319	RCT	mML - L2 - all population	pembrolizumab every 2 wk	ipilimumab	histologically confirmed, unresectable stage III or IV melanoma and had received no more than one previous systemic therapy for advanced disease	279 / 278	some concern	conclusif	demonstrated 37 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in progression or deaths (PFS) (PE) suggested 32 % decrease in deaths (OS) (extension) suggested 39 % decrease in PFS (extension)
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)
versus Standard of Care (SoC)
	nivolumab alone
	CheckMate 037, 2015 Lancet Oncol 2015;16:375-84 J Clin Oncol 2018;36:383-390 NCT01721746	RCT	mML - L2 - all population	nivolumab	chemotherapy (investigator’s choice)	patients with advanced melanoma (unresectable stage IIIC or IV metastatic melanoma, who progressed after ipilimumab, or ipilimumab and a BRAF inhibitor if they were BRAFV mutation-positive (second-line or later-line treatment).	272 / 133	high	inconclusive	inconclusive 5 % decrease in deaths (OS) (PE) suggested 2.4-fold increase in objective responses (ORR) (PE)
	pembrolizumab (10mg/kg)
	KEYNOTE-002 (10 mg/kg), 2015 Lancet Oncol. 2015; 16:908-18 Eur. J. Cancer 2017; 86:37-45 Eur. J. Cancer 2016; 67:46-54 Eur J Cancer 2020 Dec 23;144:182-191. NCT01704287	RCT	mML - L2 - all population	pembrolizumab	ICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)	18 years or older with unresectable stage III or stage IV melanoma, not amenable to local therapy; confirmed disease progression within 24 weeks of the last ipilimumab dose, previous BRAF or MEK inhibitor therapy or both,	181 / 179	some concern	conclusif	suggested 26 % decrease in deaths (OS) (PE) demonstrated 50 % decrease in progression or deaths (PFS) (PE)
	pembrolizumab (2mg/kg)
	KEYNOTE-002 (2 mg/kg), 2015 Lancet Oncol. 2015; 16:908-18 Eur. J. Cancer 2017; 86:37-45 Eur. J. Cancer 2016; 67:46-54 Eur J Cancer 2020 Dec 23;144:182-191. NCT01704287	RCT	mML - L2 - all population	pembrolizumab	ICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)	unresectable stage III or stage IV melanoma not amenable to local therapy; confirmed disease progression14 within 24 weeks of the last ipilimumab dose	180 / 179	some concern	conclusif	inconclusive 14 % decrease in deaths (OS) (PE) demonstrated 43 % decrease in progression or deaths (PFS) (PE)

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