Table 2.

Selected late phase trials of combination trials for advanced unresectable melanoma and Phase III adjuvant studies for resected high-risk melanoma

Clinical trial	Study design	Study population	N	Primary endpoint
Keynote-022 (NCT02130466)	Phase I/II trial multiple cohort study evaluating dabrafenib/trametinib/pembrolizumab combination therapy in patients with advanced BRAF mutant melanoma and trametinib/pembrolizumab in patients with advanced non-BRAF mutant melanoma	Metastatic unresectable melanoma; immune checkpoint inhibitor and BRAF/MEK inhibitor naive	219	DLT frequency in Phase I portion; PFS in Phase II portion
Keynote-034 (NCT02263508)	Phase Ib/III trial of T-VEC + pembrolizumab versus placebo + pembrolizumab	Metastatic unresectable melanoma; no prior immune checkpoint therapy; BRAF mutant melanoma patients are allowed to have had BRAF or MEK inhibitor therapy	660	DLT frequency (Phase Ib portion); PFS and OS (Phase III portion)
Keynote-252/ECHO-301 (NCT02752074)	Phase III study of pembrolizumab plus epacadostat versus pembrolizumab plus placebo in unresectable or metastatic melanoma	Metastatic unresectable melanoma; treatment naive	600	PFS and OS
Keynote-054 (NCT02362594)	Phase III study of adjuvant pembrolizumab versus placebo in resected, high-risk melanoma	Completely resected stage IIIA/B/C (>1 mm node involvement); adjuvant treatment setting	900	RFS; RFS in PD-L1-expressing patients
S1404 (NCT02506153)	Phase III study of adjuvant pembrolizumab versus high-dose interferon or ipilimumab in resected, high-risk melanoma	Completely resected stage IIIA/B/C, IV; adjuvant treatment setting	1,378	OS; RFS; OS based on PD-L1 expression; RFS based on PD-L1 expression

Note: N, number of patients to be enrolled in study.

Abbreviations:, DLT, dose-limiting toxicity; PFS, progression-free survival; OS, overall survival; RFS, recurrence-free survival; PD-L1, programmed death-ligand 1 receptor; T-VEC, talimogene laherperavec.