Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

To join this study, you would need to have been recently diagnosed with a specific type of head and neck cancer (squamous cell carcinoma) that is at certain stages (Stage III or IVA) and can be removed by surgery. This could be HPV-positive cancer in the oropharynx at a specific stage, or HPV-negative cancer in the oropharynx, or cancer in the voice box, lower throat, or mouth at Stages III or IVA.

You would also need to be fit enough for surgery, as decided by your doctor, and able to undergo scans (like CT or MRI) to measure your tumour. If you are able to have children, you and your partner would need to agree to use effective contraception during the study and for six months afterwards. Women who are pregnant or breastfeeding cannot take part. Your overall health should be good, often measured by an 'ECOG performance status' of 0 or 1, which means you're generally able to carry out your daily activities.

However, you wouldn't be able to join if your cancer has spread to distant parts of your body or is at a very advanced local stage (T4B and/or N3). The study also excludes certain types of head and neck cancer, such as those in the nasal cavity or unknown primary cancers. If you've previously had similar immunotherapy treatments (like anti-PD-1 drugs) or are pregnant, you won't be able to participate.

If you take part in this study, you would first undergo a screening process to ensure you meet all the eligibility criteria. This would involve medical checks, scans like CT or MRI, and providing a small sample of your tumour (biopsy). If eligible, you would then be randomly assigned to one of two treatment groups. One group would receive pembrolizumab medication before surgery, followed by surgery, and then further pembrolizumab along with radiotherapy (and possibly chemotherapy). The other group would have surgery followed by radiotherapy (and possibly chemotherapy) without pembrolizumab. The exact details of visits and tests would depend on your specific treatment schedule, but would involve regular checks and scans to monitor your health and the cancer. The total duration of your participation would involve the treatment period and follow-up to track your health and any return of the cancer. You would also need to use contraception for several months after your last dose of study treatment.