Phase 3 Randomized Trial Comparing Radiotherapy Plus Pembrolizumab With or Without Chemotherapy Versus Systemic Treatment Alone for Newly Diagnosed Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

This research investigates the treatment options for patients newly diagnosed with metastatic head and neck squamous cell carcinoma. It compares the effects of adding loco-regional radiotherapy and pembrolizumab alone or combined with chemotherapy against systemic treatment alone as the first-line therapy. The study is a phase 3, randomized, open-label trial conducted across multiple centers to evaluate these treatment strategies in this patient population. Participants are randomly assigned to receive either pembrolizumab with or without chemotherapy plus radiotherapy or systemic treatment alone. Pembrolizumab is given as a 200 mg dose every three weeks until disease progression or unacceptable toxicity. Radiotherapy timing varies, starting either before the third pembrolizumab cycle or after, with specific dose schedules targeting involved tumor regions. Chemotherapy, if added, includes carboplatin or cisplatin combined with 5-fluorouracil and is administered for up to six cycles depending on radiotherapy timing and investigator decisions. Throughout the study, participants undergo regular assessments to monitor disease progression and response to treatment. Key measurements include progression-free survival, overall survival, and quality of life questionnaires collected at multiple time points up to five years. Researchers also track treatment side effects, tumor responses, and compliance. The study period extends up to eight years, with primary outcome evaluation after three years and continued follow-up for survival and safety up to five years after randomization.

Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers