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NCT07470489PHASE2NOT_YET_RECRUITING

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

A Multi-Center Single-Arm Phase 2 Trial Of Zanzalintinib In Combination With Cemiplimab In BRAF Wild-Type Anaplastic Thyroid Cancer: The ZEPHYR Trial

Sponsor: M.D. Anderson Cancer Center

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Key Facts

Study type
INTERVENTIONAL
Conditions
Anaplastic Thyroid Cancer
Interventions
Cemiplimab, Zanzalintinib
Enrollment
12 participants
Primary completion
Sep 2030
Study completion
Sep 2032
First posted
Mar 2026
Last updated
Apr 2026

Primary Endpoints (CT.gov)

Safety and Adverse Events (AEs)

Time frame: Through study completion; an average of 1 year

Eligibility Criteria

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 BRAFV600

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov