Actively Recruiting
NEO-COMBAT XL: Neoadjuvant and Maintenance XL092 and Cemiplimab in BRAF V600E-wildtype Anaplastic Thyroid Cancer: a Phase 1B Study
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-11-05
12
Participants Needed
2
Research Sites
21 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
Researchers are evaluating the safety and feasibility of combining neoadjuvant XL092 and cemiplimab before surgery in people with anaplastic thyroid cancer (ATC) that does not have the BRAF V600E mutation. This phase 1B study focuses on patients with this aggressive cancer type who are scheduled for surgical removal of their tumor. The study aims to address the limited effectiveness of current chemotherapy and single-agent immunotherapy treatments in this patient group by exploring a combination therapy that has shown promise in other cancers. Participants will receive XL092 orally at a dose of 60 mg daily for 8 weeks and cemiplimab intravenously at 350 mg over 30 minutes every 3 weeks for 3 cycles during the neoadjuvant period before surgery. Surgery will follow this treatment, and additional adjuvant therapy may be given based on the surgical pathology results. The study treatments are given as part of the standard care plan alongside this research protocol. During the study, participants will undergo assessments including tumor response evaluations and monitoring for treatment-related side effects up to two years. The primary outcomes include the ability to achieve complete gross tumor removal within 12 weeks and tracking any non-blood-related adverse events. Secondary outcomes such as response rates, time to surgery, disease resectability, event-free survival, and overall survival will be followed for up to five years. Participants will have regular visits to monitor their health and treatment effects throughout the study period.
CONDITIONS
Brief Title
XL092 and Cemiplimab in BRAF WT Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained and HIPAA authorization for personal health information release.
- Willing and able to comply with study procedures per investigator judgment.
- Age 18 years or older at consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Pathologic findings supporting diagnosis of anaplastic thyroid cancer.
- Willing to have a fresh biopsy at least 3 days before neoadjuvant therapy if archival tissue is unavailable and biopsy at surgery if applicable.
- Tumor must be BRAF V600E mutation-negative by immunohistochemistry or genetic/molecular testing.
You will not qualify if you...
- Pregnant or breastfeeding; females must not breastfeed during treatment and for 1 month after last XL092 dose.
- Prior exposure to immune modulating agents or small molecule kinase inhibitors with documented disease progression.
- Ongoing or recent (within 5 years) significant autoimmune disease requiring systemic immunosuppressive treatment.
- 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 investigational clinical study within the last 3 weeks.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive neoadjuvant therapy with XL092 daily and cemiplimab intravenously every 3 weeks for 3 cycles before their scheduled surgery.
3 visits (in-person) for cemiplimab infusions and daily oral XL092 dosing
Duration - 1 day
Participants undergo surgical resection of their anaplastic thyroid cancer as part of their standard care after neoadjuvant therapy.
1 visit (in-person) for surgery
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
L
Lori Stravers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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