Disease |
Head and neck squamous cell carcinoma (HNSCC) |
Stage of disease/treatment |
Recurrent or metastatic |
Prior therapy |
Cisplatin-based chenotherapy. Anti-PD1 mmunotherapy |
Type of study |
Phase II, nonrandomized, non-blinded, single-arm study |
Primary endpoint |
The objective response rate, including confirmed complete response and confirmed partial response, according to RECIST version 1.1 |
Secondary endpoints |
Safety, progression-free survival, overall survival, pharmacokinetic analysis, and biomarkers (ctDNA, cl-NOTCH) |
Investigator’s analysis |
Active and should be pursued further |