Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Immune checkpoint inhibitors (CPI) such as pembrolizumab or nivolumab have been recently
approved for the treatment of recurrent/metastatic head and neck cancer (HNSCC). However,
only a minority of patients respond to therapy. From the clinical point of view the optimal
management of patients progressing on or after CPI therapy is still a challenge.
Retrospective analysis showed that HNSCC patients, who progressed on/after CPI, demonstrated
an overall response rate (ORR) of up to 30% subsequent to chemotherapy +/- cetuximab
treatment. It is the aim of this study to evaluate if paclitaxel plus cetuximab after first
line pembrolizumab failure is an effective salvage therapy in 50 R/M HNSCC patients. The
primary endpoint is ORR according to RECIST V 1.1.