Study of Pembrolizumab and Lenvatinib Treatment in Adults with Anaplastic Thyroid Cancer Evaluating Effectiveness and Safety in a Phase 2 Pilot Study

What this Trial Is About

Researchers are evaluating the effectiveness and safety of pembrolizumab combined with lenvatinib in patients with anaplastic thyroid cancer. This pilot Phase 2 study includes both treatment-naive patients without BRAF mutations and patients previously treated with chemotherapy or targeted therapies. The study aims to assess outcomes based on specific primary and secondary endpoints to better understand this treatment combinations potential in this aggressive cancer. Participants receive pembrolizumab intravenously every 21 days at a dose of 200 mg, combined with daily oral lenvatinib starting at 20 mg. Dose reductions for lenvatinib are allowed if toxicity occurs, but pembrolizumab dose changes are not planned. Treatment continues until cancer progression or intolerable side effects, with pembrolizumab given up to 35 cycles. Patients undergo thorough initial evaluations including scans and genetic testing before starting therapy. During the study, participants will have monthly assessments for the first six months, including clinical exams, lab tests, and imaging to monitor tumor response using iRECIST criteria. Safety is closely monitored at every treatment visit and for up to 90 days after treatment ends. Patient survival and any further cancer treatments are tracked until death or loss of contact. Treatment breaks for surgery are planned if the tumor becomes operable, with specific guidance on managing lenvatinib around surgery.

Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer