Table 6.

The key reported clinical trials of of PD-1/PD-L inhibitors in patients with anal cancer

Tumor type	Target	Drug	Phase and identification	Sample size	Clinical end point	TRAEs	Reference
AC	PD-1	Pembrolizumab	Phase I NCT02054806	25	ORR (SCCA) 17%; SD (SCCA) 42%; DCR (SCCA) 58%; SD (NSCCA) 1 patient	Any grade 64%, including diarrhea, fatigue, nausea	Annals of Oncology 2017 [166]
SCCA	PD-1	Nivolumab	Phase II NCT02314169	37	ORR 24%	Common AEs: anemia, fatigue, and rash; grade 3 AEs: anemia, fatigue, rash, and hypothyroidism.	Lancet Oncology 2017 [73]
SCCA	PD-1	Nivolumab	Phase II NCT02314169	33	PD 21%; SD 58%; DCR 79%; median PFS 4.1 months	Common AEs: fatigue, nausea, and rash; grade 3: 6 patients, including fatigue pneumonitis, rash, anemia, and hyperglycemia.	ASCO 2016 [130]
SCCA	PD-1	Pembrolizumab	Phase Ib NCT02054806	25	ORR 20%; SD 44%; PD 32%	Any grade 64%, including fatigue, diarrhea and nausea; grades 3–4 8%, including grade 3 general physical health deterioration and grade 3 thyroid-stimulating hormone increased	ECCO 2015 [132]