Zanzalintinib Plus Cemiplimab for the Treatment of BRAF Wild-Type Anaplastic Thyroid Cancer (NCT07470489) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Zanzalintinib Plus Cemiplimab for the Treatment of BRAF Wild-Type Anaplastic Thyroid Cancer
United States12 participantsStarted 2026-09-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 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.
* Patients with BRAF-wild type ATC will be eligible for this study. Patients with a BRAFV600E mutation who are unable to receive the FDA approved drugs, dabrafenib/trametinib, are also eligible as long as this is documented.
* Unless clinically contraindicated, all patients with active neck disease who have not received prior neck radiation will be considered for palliative-dose EBRT to the neck (preferably 14 Gy, but 7 to 30 Gy is acceptable) within one month prior to the initiation of study drugs. All patients eligible for palliative neck EBRT who do not undergo radiation will need t…
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year