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 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
	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)
mML - L1 - all population metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - all population
versus ipilimumab alone
	nivolumab plus ipilimumab
	CheckMate 069 (all population), 2015 N Engl J Med 2015;372:2006-17 Lancet Oncol. 2016; 17:1558-1568 NCT01927419	RCT	mML - L1 - all population	nivolumab and ipilimumab	ipilimumab	unresectable, previously untreated stage III or IV melanoma with measurable disease, with BRAF Wild-Type Tumors and BRAF mutant	95 / 47	low	conclusif	demonstrated 62 % decrease in progression or deaths (PFS) (PE) suggested 64 % decrease in PFS (extension) demonstrated 14.1-fold increase in objective responses (ORR) (PE)
	CheckMate 067 (NI vs I ; all population), 2015 N Engl J Med 2017;377:1345-1356 N. Engl. J. Med. 2019; 381:1535-1546 Lancet Oncol. 2018; 19:1480-1492 N. Engl. J. Med. 2015; 373:23-34 Eur. J. Cancer 2017; 82:80-91 Qual Life Res 2019; 28:109-119 NCT01844505	RCT	mML - L1 - all population	nivolumab plus ipilimumab	ipilimumab	patients with previously untreated, unresectable or metastatic histologically confirmed stage III or IV melanoma.	314 / 315	low	conclusif	demonstrated 45 % decrease in deaths (OS) (PE) demonstrated 58 % decrease in progression or deaths (PFS) (PE) suggested 48 % decrease in deaths (OS) (extension) suggested 58 % decrease in PFS (extension) more...
versus nivolumab alone
	nivolumab plus ipilimumab
	CheckMate 067 (NI vs N) EXPLORATORY, 2015 N Engl J Med 2017;377:1345-1356 N. Engl. J. Med. 2019; 381:1535-1546 Lancet Oncol. 2018; 19:1480-1492 N. Engl. J. Med. 2015; 373:23-34 Eur. J. Cancer 2017; 82:80-91 Qual Life Res 2019; 28:109-119 NCT01844505	RCT	mML - L1 - all population	nivolumab plus ipilimumab	nivolumab	patients with previously untreated, unresectable or metastatic histologically confirmed stage III or IV melanoma.	314 / 316	low	inconclusive	suggested 35 % decrease in deaths (OS) suggested 21 % decrease in PFS (extension) suggested 26 % decrease in progression or deaths (PFS)
	relatlimab plus nivolumab
	RELATIVITY-047 unpublished New England Journal of Medicine NCT03470922	RCT	mML - L1 - all population	relatlimab plus nivolumab	nivolumab	patient (>= 12yr) with previously untreated, unresectable or metastatic disease melanoma	-/-	NA	suggested	suggested 25 % decrease in progression or deaths (PFS) (PE)
mML - L1 - BRAF mutant metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF mutant
versus ipilimumab alone
	nivolumab plus ipilimumab
	CheckMate 069 (BRAF mutant) EXPLORATORY, 2015 N Engl J Med 2015;372:2006-17 Lancet Oncol. 2016; 17:1558-1568 NCT01927419	RCT	mML - L1 - BRAF mutant	nivolumab and ipilimumab	ipilimumab	unresectable, previously untreated stage III or IV melanoma with measurable disease, with BRAF mutant Tumors	23 / 10	low	inconclusive	no statistically significant result
mML - L1 - BRAF wild metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF wild
versus ipilimumab alone
	nivolumab plus ipilimumab
	CheckMate 069 (BRAF wild type), 2015 N Engl J Med 2015;372:2006-17 Lancet Oncol. 2016; 17:1558-1568 NCT01927419	RCT	mML - L1 - BRAF wild	nivolumab and ipilimumab	ipilimumab	unresectable, previously untreated stage III or IV melanoma with measurable disease, with BRAF Wild-Type Tumors	72 / 37	low	conclusif	demonstrated 60 % decrease in progression or deaths (PFS) (PE) demonstrated 12.0-fold increase in objective responses (ORR) (PE)

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 - L1 - BRAF mutant metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF mutant

mML - L1 - BRAF wild metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF wild