Study of Pembrolizumab Before Surgery in Adults With High-risk Differentiated Thyroid Cancer

What this Trial Is About

Researchers are evaluating the use of pembrolizumab, a checkpoint inhibitor, in treating differentiated thyroid cancer before surgery in a neoadjuvant setting. This trial focuses on high-risk thyroid cancer patients and explores how pembrolizumab affects immune cells that may help the body recognize and attack cancer cells. Pembrolizumab has been approved for other cancers but is being studied here specifically for thyroid cancer in a Phase 2 randomized trial. Participants are divided into two groups one group of about 20 patients will receive pembrolizumab 200 mg through intravenous infusion every three weeks for two doses, followed by thyroid surgery with or without radioiodine treatment based on risk. The other group of about 5 patients will receive the usual care, which is surgery followed by optional radioiodine treatment. The trial investigates the effects of pembrolizumab during the time between diagnosis and surgery, known as the window of opportunity. During the study, participants will be closely monitored through tissue and blood tests to observe changes in exhausted cytotoxic T cells up to 12 months after surgery. Researchers will assess immune responses and other clinical outcomes related to the treatment. The trial includes regular evaluations of organ function and performance status, with follow-up lasting up to one year after surgery to understand the immune systems behavior and treatment impact.

Pembrolizumab in High-risk Thyroid Cancer