Disease | Head and neck cancers |
Stage of Disease/Treatment | Metastatic/advanced |
Prior Therapy | One prior regimen |
Type of Study | Phase I, expansion cohort |
Primary Endpoint | Safety |
Additional Details of Endpoints or Study Design | Co‐primary objectives of the HNSCC expansion cohort were to (a) characterize the safety, tolerability, and dose‐limiting toxicities (DLTs) of cemiplimab in combination with RT, cyclophosphamide, and GM‐CSF and (b) evaluate the efficacy of cemiplimab in combination with RT, cyclophosphamide, and GM‐CSF by measuring ORR. |
Investigator's Analysis | Level of activity did not meet planned endpoint |