Actively Recruiting
XL092 and Cemiplimab in BRAF WT Thyroid Cancer
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-11-05
12
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
XL092 and Cemiplimab in BRAF WT Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and HIPAA authorization
- Willing and able to follow study procedures
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Pathologic findings consistent with anaplastic thyroid cancer
- Willing to have a fresh biopsy at least 3 days before neoadjuvant therapy if archival tissue is unavailable
- Must have a tumor negative for BRAF V600E mutation by immunohistochemistry or genetic/molecular testing
You will not qualify if you...
- Pregnant or breastfeeding; females should not breastfeed while receiving treatment and for 1 month after last dose of XL092
- Prior exposure to immune modulating agents or kinase inhibitors with documented disease progression on these agents
- Significant autoimmune disease requiring systemic immunosuppressive treatment within past 5 years
- History of allergic or acute hypersensitivity reactions to antibody treatments
- Receiving prohibited medications or treatments that cannot be stopped or replaced within 7 days before treatment
- Participation in another clinical study with an investigational product within the last 3 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
R
Rose Hall
CONTACT
L
Lori Stravers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here