About this trial
This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical resection in participants with wild-type (WT) anaplastic thyroid cancer (ATC) that has a BRAF mutation (BRAF V600E).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cemiplimab
- XL092
Treatment groups
Sponsors and collaborators
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Exelixis
Collaborator