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Table 1 Ongoing trials on PD1 inhibitors in HNSCC

From: PD1/PD-L1 inhibition as a potential radiosensitizer in head and neck squamous cell carcinoma: a case report

Abbreviated Trial Name/NCT# Phase Agent(s) Study population Findings/Expected Primary Endpoint Safety
KEYNOTE-012/NCT01848834 Data updated from ASCO 2016 Ib Pembrolizumab Recurrent/metastatic HNSCC ORR 17.7 % (95 % CI, 12.6–23.9 %; 7 CRs, 27 PRs).
HPV+ 21.9 %, HPV- 15.9 %.
Median OS 8.5 mo (95 % CI, 6.5–10.5).
Grade 3–4; 12 %
No treatment related deaths
KEYNOTE-055/NCT02255097 Presented ASCO 2016 II Pembrolizumab Recurrent/metastatic HNSCC, progressed on platinum and cetuximab ORR 18 % (95%CI 9–31); HPV+ 22 %, HPV- 16 %
SD 18 %
Grade 3–5; 20 %
KEYNOTE-040/NCT02252042 Ongoing III Pembrolizumab VS Chemotherapy (methotrexate, docetaxel or cetuximab) Recurrent/metastatic HNSCC PFS
OS
 
KEYNOTE-048/NCT02358031 Ongoing III Pembrolizumab VS Pembro + cis/carbo + 5FU VS Cetuximab + cis/carbo + 5FU First line treatment for recurrent/metastatic HNSCC PFS  
CheckMate141/NCT02105636 Presented AACR 2016 III Nivolumab VS Chemo (methotrexate, docetaxel or cetuximab) Recurrent/metastatic HNSCC 1 year OS; nivo 36 %, chemo 16.6 %
Median OS; nivo 7.5 mon, chemo 5.1 months