Phase II Study of Cemiplimab, With or Without Chemotherapy, Followed by Biomarker-Guided Reduced-Intensity Treatment for Advanced HPV-Related Head and Neck Cancer

What this Trial Is About

Researchers are investigating whether using neoadjuvant immunotherapy, with or without chemotherapy, can reduce the intensity of treatment for patients with advanced HPV-related head and neck squamous cell carcinoma while maintaining high cure rates and improving long-term quality of life. This Phase II trial focuses on patients with confirmed HPV16-positive tumors and aims to evaluate treatment feasibility and quality of life outcomes. Participants will receive three cycles of Cemiplimab through intravenous infusion over nine weeks before their main curative treatment. Some may also receive chemotherapy drugs Carboplatin and Paclitaxel depending on individual benefit. After this initial phase, a multidisciplinary team will decide whether patients undergo de-escalated treatment, such as Transoral Robotic Surgery TORS or low-dose radiation therapy 42 Gy, or non-minimally de-escalated treatment including surgery followed by post-operative radiation or chemoradiation therapy. Following curative treatment, patients will receive adjuvant Cemiplimab for four months, administered as five doses every 21 days. During the study, participants will be closely monitored weekly by a multidisciplinary team and assessed at weeks 9 or 10 to guide treatment decisions. Researchers will measure progression-free survival and changes in swallowing function and quality of life through specific questionnaires over two years. Safety will be tracked by recording any significant toxicities or immune-related adverse events. This study will last up to two years and includes detailed follow-up to evaluate the effectiveness and impact of the treatment approach on patient well-being.

Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca