Treatment with Carboplatin, Paclitaxel, and Cetuximab After Pembrolizumab Failure in Adults with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

This research aims to evaluate treatment options for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC who have experienced disease progression after first-line treatment with pembrolizumab, with or without chemotherapy. The study focuses on patients who need a second line of treatment and investigates the objective response rate to a combination therapy called PCC Paclitaxel, Carboplatin, and Cetuximab. It also monitors disease progression, treatment tolerance, and quality of life over 12 months. Participants receive the PCC protocol, which involves intravenous injections of paclitaxel, carboplatin, and cetuximab administered in cycles lasting one week each for 16 cycles. The carboplatin and paclitaxel are given three weeks out of four, alongside weekly cetuximab. After these cycles, maintenance treatment with cetuximab is given every 14 days until unacceptable side effects, disease progression, or death occurs. During the study, patients will undergo evaluations every 90 days for up to 12 months to measure tumor response and progression. Researchers will assess survival outcomes, treatment safety, and quality of life. Follow-ups may continue according to local practice for up to five years, including monitoring progression-free survival and overall survival. The total participation duration is 12 months, with ongoing safety and quality of life assessments.

Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck