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Table 6 The key reported clinical trials of of PD-1/PD-L inhibitors in patients with anal cancer

From: PD-1/PD-L blockade in gastrointestinal cancers: lessons learned and the road toward precision immunotherapy

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]