Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC

This study is for adults aged 18 or over who have been diagnosed with a specific type of head and neck cancer (squamous cell carcinoma) that is considered advanced but has not spread widely. You would have already completed a full course of chemotherapy and radiotherapy for this cancer.

Crucially, checks will be done on your cancer cells to ensure they have a specific marker called PD-L1. Your cancer also needs to have remained stable or improved after your initial chemoradiotherapy, which will be checked with scans. You can't have had any new cancer growth since your initial treatment.

For safety, both men and women must agree to use effective contraception during the study and for several months afterwards. Women must not be pregnant or breastfeeding. All participants must be able to understand and sign a consent form.

If you decide to take part, you'll first have some checks to make sure you're suitable for the study. If you are, you'll be randomly put into one of two groups: one group will receive pembrolizumab only, and the other will receive pembrolizumab combined with lenvatinib. You and your doctors will know which treatment you're getting.

Pembrolizumab is given directly into a vein every three weeks. If you're in the combination group, you'll also take lenvatinib as a tablet once a day, which will start a few weeks after your first pembrolizumab dose. You'll begin treatment within two weeks of finishing your main chemoradiotherapy. Treatment will continue for up to 12 months, or until the cancer grows, or if you experience side effects that are too difficult to manage.

After finishing treatment, you'll be monitored with regular check-ups for two years to see how you're doing. This will involve hospital visits, scans, and possibly other tests to keep an eye on your health and the cancer. The total duration from starting treatment to the end of follow-up will be about two years.