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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

 
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