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

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

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