M.D. Anderson Cancer Center
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.
Primary Objective: The study's primary objective is to determine the overall survival (OS) of zanzalintinib plus cemiplimab in treatment-naïve BRAF wild type ATC patients. Secondary Objectives: * Determine the 6-month OS rate with zanzalintinib plus cemiplimab in treatment-naïve BRAF wild type ATC patients * Determine the objective response rate (ORR) and progression-free survival (PFS) in patients treated with zanzalintinib plus cemiplimab, per RECIST v1.1 * Determine the metabolic response rate (MRR) to zanzalintinib plus cemiplimab, per PERCIST 1.0 in patients undergoing serial 18F-FDG P…
Inclusion Criteria: * 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 epitheli…
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