Pembrolizumab + Radiotherapy for Head and Neck Cancer

This trial investigates whether pembrolizumab (an immunotherapy drug), administered before and after surgery with radiotherapy (and sometimes the chemotherapy drug cisplatin), can help individuals with certain types of head and neck cancer live longer without recurrence. The study focuses on those with newly diagnosed, non-metastatic head and neck squamous cell carcinoma, specifically in the oropharynx, larynx, hypopharynx, or oral cavity. Individuals who have never undergone cancer treatment, have surgically removable tumors, and meet specific cancer stages may be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any form of immunosuppressive therapy, you may need to stop as these are part of the exclusion criteria.

Research shows that pembrolizumab, the treatment under study, has been used in other trials for head and neck cancer. In these studies, patients have generally tolerated pembrolizumab well. For example, one study found no new safety concerns when administered before surgery, suggesting it is unlikely to cause unexpected problems.

Patients might experience side effects, but they are usually manageable. Another study found that while serious side effects can occur, they are not common. Pembrolizumab is already FDA-approved for other uses, which supports its safety.

Pembrolizumab is unique because it harnesses the power of the immune system to fight head and neck cancer by blocking a protein that prevents the immune system from attacking cancer cells. Most treatments for this condition, like surgery followed by standard radiotherapy and chemotherapy, directly target and attempt to destroy cancer cells. Pembrolizumab, however, works differently by enhancing the body's natural defenses to recognize and destroy cancer. Researchers are excited because this approach has the potential to improve outcomes and reduce side effects compared to traditional treatments.

Research has shown that adding pembrolizumab to standard treatments can significantly improve outcomes for patients with advanced head and neck cancer. In this trial, one arm uses pembrolizumab before and after surgery, which studies have shown helps patients live longer without cancer recurrence. Another study demonstrated that pembrolizumab, particularly in patients with high PD-L1 scores, extended survival compared to standard treatments alone. This suggests that pembrolizumab may offer a better chance of controlling the disease and increasing lifespan for those with this type of cancer.¹⁵⁶⁷⁸