XL092 and Cemiplimab in BRAF WT Thyroid Cancer

{ "XL092 and Cemiplimab for BRAF WT Thyroid Cancer", "This study is looking at a new way to treat anaplastic thyroid cancer (ATC) that is wild-type (WT) for the BRAF gene (meaning it doesn't have the BRAF V600E mutation). It combines two medicines, XL092 and cemiplimab, given before surgery. Researchers want to see if this combination is safe and works well for people with this aggressive type of thyroid cancer. You might be able to join if you are 18 or older, have ATC that is BRAF WT, and are planning to have surgery. The study will look at how many people have a complete removal of their tumor and any side effects from the treatment.", "design": "This is a study with 12 participants. It is testing the combination of XL092 and cemiplimab before surgery.", "commitments": "You would receive cemiplimab intravenously (through a vein) every 3 weeks for 3 cycles, and XL092 by mouth daily for 8 weeks. You would be monitored for side effects for up to 2 years.", "compensation": "Not stated in the trial record.", "follow_up": "You would be followed for non-hematologic treatment-related adverse events (side effects not related to blood) for up to 2 years.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

XL092 and Cemiplimab in BRAF WT Thyroid Cancer

Recruiting

PHASE1Ages 18+InterventionalTreatment

UNC Lineberger Comprehensive Cancer Center

~12 participants

Updated 2025-11-05 on ClinicalTrials.gov

What's tested:CemiplimabXL092

At a glance

Recruiting sites

1 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Complete gross resection

Measured over 12 weeks

+1 more outcome measured

Conditions

Anaplastic Thyroid Cancer

Thyroid Cancer

BRAF Mutation-Related Tumors

Where it's being run

2 sites across 2 states

Massachusetts1

North Carolina1

Study leadership

Siddharth Sheth, DO MPH · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Rose Hall

[email protected]

1-(919) 966-0808

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.

Subjects are willing and able to comply with study procedures based on the judgment of the investigator.

Age ≥ 18 years at the time of consent.

the Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Pathologic findings supporting the clinical impression of anaplastic thyroid cancer. Terminology consistent or suggestive of diagnosis may include the following: 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.

Subject is willing to have a fresh biopsy at least 3 days prior to neoadjuvant therapy if archival tissue is unavailable. Also willing to have a biopsy at the time of SOC surgery, if applicable.

Must have BRAF V600E mutation-negative tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue or genetic/molecular testing of the tumor.

Exclusion

Pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study). Females should not breastfeed while receiving study treatment and for 1 month from the last dose of XL092.

Patients who have had prior exposure to any immune modulating agents or any type of small molecule kinase inhibitor (including investigational agents) and have documented disease progression on these agents will not be eligible.

Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments (i.e., with use of disease modifying agents, corticosteroids (\>10 mg of prednisone or equivalent) or immunosuppressive drugs) which may suggest risk of immune-mediated Adverse Events.

Replacement therapy (e.g.: thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.

Subject history of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments.

Subject is receiving prohibited medications or treatments as listed in the protocol that cannot be discontinued/replaced by an alternative therapy within 7 days of initiating treatment.

Participation in another clinical study with an investigational product during the last 3 weeks.

What this trial measures

Complete gross resection12 weeks
Complete gross resection (CGR) is defined as the proportion of patients who undergo successful thyroidectomy with negative (R0) or microscopically positive (R1) surgical margins.
Non-hematologic treatment related adverse events (TRAEs)Up to 2 years
Non-hematologic treatment related adverse events (TRAEs) with neoadjuvant and maintenance XL092 and cemiplimab will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI- CTCAE) v5.0.

Trialytics