Table 5.

Available data for immune checkpoint inhibitor monotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck (14, 67, 80).^a

NCT #	No. of Patients	Eligibility	Drug	Available data			Toxicity findings
				Median PFS, months	Median OS, months	ORR, %
NCT02105636 (CheckMate 141) (67)	361		Nivolumab	2	7.5	13.3	13.1% of patients experienced grade 3–4 TRAEs
							2 patients died due to TRAE (1 pneumonitis and 1 hypercalcemia)
NCT01848834 (expanded KEYNOTE-012) (80)	60	PD-L1+	Pembrolizumab	2	13	18	17% of patients experienced grade 3–4 TRAEs
	132	Any PD-L1 status		2	8	18	No treatment-related deaths were reported
							About 9% of patients experienced grade 3–4 TRAEs
							No treatment-related deaths were reported
NCT02255097 (KEYNOTE-055) (14)	171		Pembrolizumab	2.1	8	16	26 patients (15%) experienced grade 3–5 TRAEs
							1 patient died of treatment-related pneumonitis

NCT, ClinicalTrials.gov identifier; ORR, overall response rate; OS, overall survival; PD-L1, programmed cell death ligand 1; PFS, progression-free survival; TRAE, treatment-related adverse event.

^aThe values in this table reflect the PFS, OS, and ORR recorded for the populations of each trial regardless of PD-L1 expression status (14, 67, 80).