Combining XL092 and cemiplimab for BRAF V600E–wildtype anaplastic thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter Phase 1 trial testing the safety and feasibility of a neoadjuvant combination of the tyrosine kinase inhibitor XL092 with the PD-1 inhibitor cemiplimab in patients with BRAF V600E–wildtype anaplastic thyroid cancer scheduled for surgical resection. Eligible adults receive the combination therapy prior to their planned standard-of-care surgery, with on-study and surgical biopsies to characterize response and biomarkers. Primary endpoints focus on safety, tolerability, and the feasibility of administering the combination before surgery, with secondary observations of radiographic and pathologic tumor response. The trial is sponsored by UNC Lineberger with sites including Dana-Farber/Harvard and UNC Chapel Hill and includes industry collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Dana Farber/Harvard Cancer Center
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Siddharth Sheth, DO MPH — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Rose Hall
• Email: rose_hall@med.unc.edu
• Phone: 1-(919) 966-0808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.