metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mML - L1 - all population metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - all population
versus ipilimumab alone
	nivolumab alone
	CheckMate 067 (N 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 J Clin Oncol 2022; 40:127-137-. NCT01844505	RCT	mML - L1 - all population	nivolumab	ipilimumab	with previously untreated, unresectable or metastatic histologically confirmed stage III or IV melanoma.	316 / 315	low	conclusif	demonstrated 37 % decrease in deaths (OS) (PE) demonstrated 43 % decrease in progression or deaths (PFS) (PE) suggested 37 % decrease in deaths (OS) (extension) suggested 47 % decrease in PFS (extension) more...
	nivolumab plus ipilimumab
	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...
	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)
versus ipilimumab followed by nivolumab
	nivolumab followed by ipilimumab
	CheckMate 064, 2016 Lancet Oncol. 2016; 17:943-955 NCT01783938	RCT	mML - L1 - all population	nivolumab followed by ipilimumab	ipilimumab followed by nivolumab	unresectable stage III or stage IV melanoma, and were previously untreated or had progressed after no more than one previous systemic therapy	68 / 70	high	suggested	suggested 52 % decrease in deaths (OS)
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)
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 - 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
versus placebo plus SoC
	atezolizumab plus SoC
	IMspire-150 (BRAF mutant), 2020 Lancet 2020; 395:1835-1844 NCT02908672	RCT	mML - L1 - BRAF mutant	atezolizumab plus cobimetinib plus vemurafenib	placebo plus cobimetinib plus vemurafenib	patients previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.	256 / 258	low	suggested	suggested 22 % decrease in progression or deaths (PFS) (PE)
mML - L1 - BRAF wild metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF wild
versus dacarbazine
	nivolumab alone
	CheckMate 066, 2015 N Engl J Med 2015;372:320-30 JAMA Oncol 2019; 5:187-194 Ann. Oncol. 2016; 27:1940-6 NCT01721772	RCT	mML - L1 - BRAF wild	nivolumab	dacarbazine	previously untreated patients who had unresectable metastatic melanoma without a BRAF mutation (stage III or IV).	210 / 208	low	conclusif	demonstrated 58 % decrease in deaths (OS) (PE) demonstrated 57 % decrease in progression or deaths (PFS) (PE) suggested 54 % decrease in deaths (OS) (extension) suggested 58 % decrease in PFS (extension) more...
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)
versus pembrolizumab alone
	atezolizumab plus cometinib
	IMspire-170, 2020 Ann Oncol 2020 Dec 10;S0923-7534(20)43203-X. NCT03273153	RCT	mML - L1 - BRAF wild	cometinib plus atezolizumab	pembrolizumab	patient with confirmed locally advanced and unresectable or metastatic melanoma that was negative for BRAFV600 mutations with no prior systemic treatment for advanced melanoma.	222 / 224	some concern	inconclusive	inconclusive 15 % increase in progression or deaths (PFS) (PE)

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