Table 1.
Ongoing trials on PD1 inhibitors in HNSCC
| 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 |