drugset / Trial / NCT04278092

Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure

NCT04278092 ↗

Phase 2 Completed 57 enrolled Medical University of Vienna
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-02-10
Primary completion
2024-10-31
Completion
2024-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 —
Subject Paclitaxel Small molecule 175 mg/m2 —