Phase II Trial Comparing Chemotherapy and Radiation With or Without Pembrolizumab in Advanced Laryngeal or Hypopharyngeal Cancer Eligible for Laryngectomy

What this Trial Is About

This trial investigates advanced stage III and IV head and neck squamous cell carcinoma of the larynx or hypopharynx with PD-L1 expression, focusing on patients eligible for total laryngectomy. Researchers are comparing standard treatment involving induction chemotherapy with docetaxel and cisplatin followed by radiation to a similar treatment plus the addition of pembrolizumab, a PD-1 inhibitor. The goal is to evaluate whether adding pembrolizumab improves laryngectomy-free survival and other outcomes. Participants are randomly assigned to one of two groups. The standard group receives one cycle of induction chemotherapy followed by response evaluation responders get two more cycles and then radiotherapy, while nonresponders undergo total laryngectomy plus selective neck dissection and postoperative radiation or chemoradiation. The experimental group receives the same chemotherapy and radiation schedule plus pembrolizumab given intravenously every three weeks for up to 12 months, regardless of initial response or subsequent treatments. During the study, participants undergo tumor surface shrinkage assessment after the first chemotherapy cycle to guide treatment decisions. Researchers will monitor laryngectomy-free survival over 24 to 48 months, along with swallowing quality assessed by FEES, event-free survival, and overall survival. Safety, functional outcomes, and long-term follow-up are included, with evaluations continuing for up to four years. The total participation duration varies depending on individual response and follow-up.

European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]