Cemiplimab for Head and Neck Cancer

This trial tests cemiplimab, an immunotherapy treatment, to evaluate its effectiveness before surgery for patients with operable head and neck cutaneous squamous cell cancer. Cemiplimab, a monoclonal antibody, aids the immune system in targeting and attacking cancer cells. The study includes patients with stage II-IV cancer that has recurred after treatment and who plan to undergo surgery. Participants must have a biopsy-confirmed diagnosis and a treatment plan involving surgery, with or without radiation. As a Phase 2 trial, this research measures cemiplimab's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in cancer treatment.

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like systemic immunosuppressive medications and investigational agents must be stopped before starting the trial. It's best to discuss your specific medications with the trial team.

Research has shown that cemiplimab is generally well-tolerated. Studies on patients with advanced cutaneous squamous cell carcinoma, a type of skin cancer, indicate that many respond well to the treatment. In one study, cemiplimab caused visible signs of cancer shrinking or disappearing in 44% to 50% of patients.

Side effects are common but usually manageable. The most reported issues include tiredness, diarrhea, itching, and nausea, affecting about 27% to 42% of patients. Importantly, these side effects were not severe enough to stop most people from continuing treatment.

Cemiplimab is unique because it targets the PD-1 pathway, which is a different approach compared to traditional chemotherapy or radiation treatments for head and neck cancer. This immunotherapy works by unleashing the immune system to recognize and attack cancer cells, potentially leading to better outcomes with fewer side effects. Researchers are excited about cemiplimab because it can be administered intravenously in short 30-minute sessions every three weeks, offering a more convenient option for patients.

Research has shown that cemiplimab, a type of immunotherapy, yields promising results in treating head and neck skin cancer. One study found that cemiplimab reduced the risk of cancer recurrence or death by 68%, highlighting its potential effectiveness. Cemiplimab aids the body's immune system in identifying and attacking cancer cells, thereby slowing or stopping their growth. Patients tolerated it well, with more than half responding positively to the treatment. This evidence supports cemiplimab as a potentially effective option for treating this cancer. Participants in this trial will receive cemiplimab, with or without radiation therapy, based on the treating physician's discretion.¹²³⁶⁷