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 placebo
	pembrolizumab alone
	KEYNOTE 054 (all population), 2018 N. Engl. J. Med. 2018; 378:1789-1801 JAMA Oncol 2020; : European Journal of Cancer 2019; 116:148-. J Clin Oncol 2020 Sep 18;JCO2002110. J Med Econ 2019 Oct;22(10):981-993. JAMA Oncol 2020; 6:519-527 Lancet Oncol 2021 Apr 12;S1470-2045(21)00065-6. Lancet Oncol 2021 Apr 12;S1470-2045(21)00081-4. NEJM Evidence NCT02362594	RCT	mML - NA - all population	pembrolizumab	placebo	patients with complete Resection of High-Risk Stage III Melanoma, stage IIIA, IIIB or IIIC melanoma with no in-transit metastases,	514 / 505	low	conclusif	demonstrated 43 % decrease in RFS/DFS (PE) suggested 47 % decrease in MFS suggested 44 % decrease in RFS (extension) suggested 41 % decrease in RFS (extension) more...
mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive
versus placebo
	pembrolizumab alone
	KEYNOTE 054 (PDL1>1%), 2018 N. Engl. J. Med. 2018; 378:1789-1801 JAMA Oncol 2020; : European Journal of Cancer 2019; 116:148-. J Clin Oncol 2020 Sep 18;JCO2002110. J Clin Oncol 2020 Nov 20;38(33):3925-3936. J Med Econ 2019 Oct;22(10):981-993. Lancet Oncol 2021 Apr 12;S1470-2045(21)00065-6. Lancet Oncol 2021 Apr 12;S1470-2045(21)00081-4. NCT02362594	RCT	mML - NA - PDL1 positive	pembrolizumab	placebo	patients with complete Resection of High-Risk Stage III Melanoma, stage IIIA, IIIB or IIIC melanoma with no in-transit metastases, with PDL1 positive status	428 / 425	low	conclusif	demonstrated 46 % decrease in RFS/DFS (PE) suggested 43 % decrease in RFS (extension) demonstrated 40 % decrease in DMFS (PE)
mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population
versus ipilimumab alone
	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 Standard of Care (SoC)
	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 - BRAF mutant metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - BRAF mutant
versus placebo plus SoC
	pembrolizumab plus SoC
	KEYNOTE-022, 2019 Nat. Med. 2019; 25:941-946 Nat Med 2019 Jun;25(6):936-940. NCT02130466	RCT	mML - L2 - BRAF mutant	pembrolizumab, with dabrafenib and trametinib	placebo with dabrafenib and trametinib	patients with BRAFV600-mutant with advanced unresectable stage III or metastatic stage IV melanoma AND has received prior systemic therapy	60 / 60	low	inconclusive	inconclusive 34 % decrease in progression or deaths (PFS) (PE)

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

mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive

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

mML - L2 - BRAF mutant metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - BRAF mutant