Table 2.
Ongoing studies on PD1 inhibitors and radiation therapy in HNSCC
| Abbreviated Trial Name/NCT# | Phase | Agent(s) | Study population | Expected Primary Endpoint |
|---|---|---|---|---|
| NCT01935921 | Ib | Cetuximab, ipilimumab and IMRT | stage III-IVa HPV+ OPSCC |
Dose limiting toxicities (DLT) |
| RTOG 3504 NCT02764593 |
III w/phase I lead in | Nivolumab and cisplatin CRT | stage III-IV, intermediate to high risk HNSCC | DLT for phase I |
| NCT02777385 | II | Concurrent vs sequential pembro, cisplatin and IMRT | stage III-IVb HNSCC |
1 year PFS 1 year failure rate Acute toxicity rates |
| HN003 NCT02775812 |
I | Adjuvant pembro, cisplatin and IMRT | high risk stage III-IV HSNCC | DLT |
| NCT02641093 | II | Adjuvant pembro, cisplatin and IMRT | high risk stage III-IV HSNCC | Treatment related adverse events (TRAE) Disease free survival (DFS) |