Study	Phase	Study arms	Patient population	Primary endpoint	Updated results
KEYNOTE-006 (NCT01866319)[@382740; @382741; @382742]	III	Pembrolizumab (two dosing schedules) vs ipilimumab	Advanced melanoma	PFS and OS	7-year OS rates: 37.8% (combined pembrolizumab) vs 25.3% mOS: 32.7 mo vs 15.9 mo HR: 0.70 (95% CI: 0.58–0.83)
KEYNOTE-716 (NCT03553836)[@382743; @382744; @382745]	III	Pembrolizumab vs placebo	Newly diagnosed resected, high-risk, stage II melanoma	RFS	mFU: 39.4 mo RFS rates: 85% vs 76% mRFS: NR vs NR HR: 0.62 (95% CI: 0.49−0.79)
KEYNOTE-054 (NCT02362594)[@382746; @382747]	III	Pembrolizumab vs placebo	Resected, high-risk, stage III and ipilimumab- refractory melanoma	RFS in ITT and PD-L1+ tumors	5-year RFS rates: 55.4% vs 38.3% HR: 0.61 (95% CI: 0.51–0.72) 5-year dMFS rates: 60.6% vs 44.5% HR: 0.62 (95% CI: 0.52–0.75)
CheckMate 067 (NCT01844505)[@382734; @382738; @382748]	III	Nivolumab plus ipilimumab vs ipilimumab plus placebo	Treatment-naïve, unresectable stage III/IV melanoma	PFS and OS	mFU: 7.5 years mOS: 72.1 mo vs 36.9 mo vs 19.9 mo 7.5-year OS rates: 48% vs 42% vs 22%
CheckMate 238 (NCT02388906)[@382749; @382750; @382751]	III	Nivolumab vs ipilimumab	Resected stage III/IV melanoma	RFS	5-year RFS rates: 50% vs 39% HR: 0.72 (95% CI: 0.60–0.86) dMFS rates: 58% vs 51% OS rates: 76% vs 72%
CheckMate 069 (NCT01927419)[@382752; @382753; @382754]	II	Nivolumab plus ipilimumab vs ipilimumab plus placebo	Newly diagnosed, stage III/IV melanoma	ORR in patients with BRAF^V600 wt melanoma	ORR: 61% vs 11% (CR: 22% vs 0%) mRFS: NR vs 4.4 mo 2-year OS rates: 63.8% vs 53.6% Recent update: scRNAseq analysis of resistance mechanisms
RELATIVITY-047 (NCT03470922)[@382755; @382756]	II/III	Nivolumab plus relatlimab vs nivolumab alone	Treatment-naïve metastatic/unresectable melanoma	PFS	mFU: 19.3 mo mPFS: 10.1 mo vs 4.6 mo HR: 0.78 (95% CI: 0.64–0.94) mOS: NR vs 34.1 mo HR: 0.80 (95% CI: 0.64–1.01); p=0.059
COLUMBUS (NCT01909453)[@382735; @382757; @382758]	III	Encorafenib plus binimetinib vs vemurafenib (or encorafenib)	*Advanced BRAF^V600m melanoma*	PFS	7-year PFS rates: 21.2% vs 6.4% 7-year OS rates: 27.4% vs 18.2%
IMspire150 (NCT02908672)[@382759; @382760]	III	Atezolizumab plus vemurafenib and cobimetinib vs placebo plus vemurafenib and cobimetinib	*Newly diagnosed unresectable BRAF^V600m advanced melanoma*	PFS	mFU: 29.1 mo mOS: 39 mo vs 25.8 mo HR: 0.84 (95% CI: 0.66–1.06); p=0.14
SECOMBIT (NCT02631447)[@382761; @382762; @382763]	II	Arm A: encorafenib plus binimetinib → ipilimumab plus nivolumab; Arm B: ipilimumab plus nivolumab → encorafenib plus binimetinib; Arm C: encorafenib plus binimetinib → ipilimumab plus nivolumab → encorafenib plus binimetinib	*Treatment-naïve, metastatic BRAF^V600m melanoma*	OS	3-year OS rates: 53% vs 64% vs 61% 4-year OS rates: 46% vs 64% vs 59%
NIBIT-M4 (NCT02608437)[@382764; @382765]	Ib	Guadecitabine plus ipilimumab	Unresectable stage III/IV melanoma	Safety, tolerability and MTD	mFU: 45 months mOS: 25.6 mo; 5-year OS rate: 28.9% mPFS: 5.2 mo; 5-year PFS rate: 5.3%
C-144-01 (NCT02360579)[@382766; @382767]	II	TIL (lifileucel)	Advanced melanoma previously treated with ICIs and BRAF/MEKi	ORR	mFU: 48.1 mo; ORR: 31.4% 1-, 2-, 3- and 4-year OS rates: 54.0%, 33.9%, 28.4% and 21.9%
NCT00937625, NCT02379195 and NCT02354690[@382768]	I/II	TIL	Metastatic/locally advanced or unresectable stage III/IV melanoma	Safety and response rates	Minimum FU 5 years; 1 CR, 7 CMRs, 14 PRs, 6 PMRs
NCT04217473[@382769]	I	Oncolytic adenovirus TILT-123 plus TIL	Stage IV melanoma	Safety	1 CR, 1 PR, 2 SD cases (>10 mo)

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