Phase 1B Study of Neoadjuvant XL092 and Cemiplimab Before Surgery in Patients with BRAF V600E-Wildtype Anaplastic Thyroid Cancer

What this Trial Is About

Researchers are evaluating the safety and feasibility of combining neoadjuvant XL092 and cemiplimab before surgery in people with anaplastic thyroid cancer ATC that does not have the BRAF V600E mutation. This phase 1B study focuses on patients with this aggressive cancer type who are scheduled for surgical removal of their tumor. The study aims to address the limited effectiveness of current chemotherapy and single-agent immunotherapy treatments in this patient group by exploring a combination therapy that has shown promise in other cancers. Participants will receive XL092 orally at a dose of 60 mg daily for 8 weeks and cemiplimab intravenously at 350 mg over 30 minutes every 3 weeks for 3 cycles during the neoadjuvant period before surgery. Surgery will follow this treatment, and additional adjuvant therapy may be given based on the surgical pathology results. The study treatments are given as part of the standard care plan alongside this research protocol. During the study, participants will undergo assessments including tumor response evaluations and monitoring for treatment-related side effects up to two years. The primary outcomes include the ability to achieve complete gross tumor removal within 12 weeks and tracking any non-blood-related adverse events. Secondary outcomes such as response rates, time to surgery, disease resectability, event-free survival, and overall survival will be followed for up to five years. Participants will have regular visits to monitor their health and treatment effects throughout the study period.

XL092 and Cemiplimab in BRAF WT Thyroid Cancer