Spots Global Cancer Trial Database for Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure

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Trial Identification

Brief Title: Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure

Official Title: Paclitaxel Plus Cetuximab for the Treatment of Recurrent and/or Metastatic Head and Neck Cancer After First-line Checkpoint Inhibitor Failure: A Multicenter, Single Arm Study

Study ID: NCT04278092

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Paclitaxel

Cetuximab

Study Description

Brief 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.

Detailed Description: