Condition: Head and Neck Squamous Cell Carcinoma (HNSCC) · Recurrent Head and Neck Cancer · Metastatic Head and Neck Cancer · Sponsor: Gruppo Oncologico del Nord-Ovest
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 therapy for their advanced disease. By testing this sequential treatment strategy, researchers hope to improve outcomes for this specific patient population, which has shown poorer responses to existing immunotherapy options compared to those with higher PD-L1 expression levels. Participants will first undergo an induction phase, consisting of three cycles of chemotherapy with paclitaxel, platinum (cisplatin or carboplatin), and cetuximab. After this initial treatment, they will move to a maintenance phase, where they will receive avelumab and cetuximab every two weeks until disease progression or the occurrence of unacceptable side effects. The study aims to answer several key questions: Can this treatment approach improve progression-free survival at 6 months? What impact does it have on overall survival, response rates, and the duration of response? Is this combination therapy safe an…
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Contact details are listed per location below or on the registry record.
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| Ospedale Oncologico "A. Businco" ARNAS BROTSU | Cagliari, CAGLIARI, Italy | Not Yet Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico-S. Marco | Catania, CATANIA, Italy | Not Yet Recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence, FIRENZE, Italy | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori (INT) di Milano | Milan, Milano, Italy | Recruiting |
| Irccs Humanitas Research Hospital | Rozzano, Milano, Italy | Not Yet Recruiting |
| Irccs Fondazione G. Pascale | Naples, Napoli, Italy | Recruiting |
| AOU Luigi Vanvitelli | Naples, NAPOLI, Italy | Not Yet Recruiting |
| Azienda Ospedaliero-Universitaria Sant'Andrea | Roma, roma, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06869473