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.

This phase II interventional clinical trial aims to evaluate whether combining cetuximab and avelumab, after three cycles of platinum and taxane-based chemotherapy, can improve treatment outcomes for patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) with a PD-L1 combined positive score (CPS) between 1 and 19. Specifically, the study seeks to determine if this approach can increase the 6-month progression-free survival (PFS) rate from 40% to 55%. The trial will include adult patients with confirmed R/M HNSCC, who have not previously received systemic the

Trial Details

NCT ID
NCT06869473
Phase
PHASE2
Sponsor
Gruppo Oncologico del Nord-Ovest
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Cetuximab/avelumab
Locations (sample)
  • Cagliari, CAGLIARI, Italy|39.23054,9.11917
  • Catania, CATANIA, Italy|37.49223,15.07041
  • Florence, FIRENZE, Italy|43.77925,11.24626
  • Milan, Milano, Italy|42.78235,12.59836
  • Rozzano, Milano, Italy|45.38193,9.1559

Key Eligibility Criteria

  • Subjects able to sign the informed consent and ≥18 y-old.
  • Histologically or cytologically confirmed diagnosis of HNSCC.
  • Confirmed R/M HNSCC (i.e. oral cavity, oropharynx, larynx, hypopharynx) not suitable for curative loco-regional therapy.
  • PD-L1 CPS≥1≤19 (assessment allowed either on primary and/or recurrent/metastatic site of disease).

For full eligibility, visit ClinicalTrials.gov.

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