Phase II Study of Cetuximab with Platinum and Taxane Chemotherapy Followed by Avelumab and Cetuximab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with PD-L1 CPS 1-19

What this Trial Is About

Researchers are evaluating a new treatment sequence for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC who have a PD-L1 combined positive score CPS between 1 and 19. This phase II trial explores whether starting with chemotherapy combined with cetuximab, followed by maintenance therapy with avelumab and cetuximab, can improve six-month progression-free survival compared to prior therapies. The study addresses the unmet need for patients who respond less well to current immunotherapies. Participants will first receive an induction phase of three cycles of chemotherapy with paclitaxel, a platinum drug cisplatin or carboplatin, and cetuximab over nine weeks. Those who respond or have stable disease will then enter a maintenance phase, receiving intravenous avelumab and cetuximab every two weeks until the disease worsens or side effects become unacceptable. The study includes translational research with blood and tumor tissue samples to better understand treatment effects on tumor biology and immune response. During the trial, participants will undergo regular assessments to monitor disease progression, overall survival, response rates, and treatment safety for up to 12 months. Blood and tumor samples will be collected at specific times to study biomarkers and immune cell changes. The primary measure is progression-free survival at six months, and safety will be closely followed. The total duration depends on individual response and tolerance of treatment.

Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19.