drugset / Trial / NCT07470489

Zanzalintinib Plus Cemiplimab for the Treatment of BRAF Wild-Type Anaplastic Thyroid Cancer

NCT07470489

Phase 2 Not yet recruiting 12 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-09-30
Primary completion
2030-09-01
Completion
2032-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemiplimab Monoclonal antibody 350 mg Intravenous
Subject Zanzalintinib Small molecule 60 mg Intravenous