The goal of the trial is to improve this OS by 4 months (to 9.9 months) using the zanzalintinib + cemiplimab treatment combination. Given an accrual period of 24 months and a maximum follow-up time of 36 months, at the significance level of 0.1, to achieve the power of 0.8, the sample size needed is 24 patients and the number of events required is 17. These results are based on a one-sided test with exponential assumption for survival time.
Male/female participants who are at least 18 years of age on the day of signing informed consent
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma. Diagnosis may include consistent with or suggestive of terminology associated with anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.
Patients deemed to have unresectable locoregional disease (stage IVB) or metastatic disease (stage IVC). Patients who are unwilling to undergo surgery or external beam radiation are also eligible.
Prior treatment with zanzalintinib or any other multikinase inhibitor (e.g. lenvatinib, sorafenib, vandetanib, cabozantinib).
Prior treatment with cemiplimab or any other immune checkpoint inhibitor or immunotherapy (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, BITEs).
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives before first dose of study treatment, whichever is longer.
Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment