RecruitingPhase 1NCT06902376

XL092 and Cemiplimab in BRAF WT Thyroid Cancer

NEO-COMBAT XL: Neoadjuvant and Maintenance XL092 and Cemiplimab in BRAF V600E-wildtype Anaplastic Thyroid Cancer: a Phase 1B Study


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

12 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of XL092 (a targeted therapy) and cemiplimab (an immunotherapy) for patients with anaplastic thyroid cancer (an aggressive, rare form of thyroid cancer) that does not have a BRAF mutation. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of anaplastic thyroid cancer (BRAF wild-type, meaning no BRAF V600E mutation) - Your overall physical health allows participation (ECOG performance status 0-2) - Your organ function (kidneys, liver, blood) meets required levels **You may NOT be eligible if...** - Your tumor tests positive for BRAF V600E mutation - You have active, untreated brain metastases - You have a history of severe autoimmune disease - You are pregnant or breastfeeding - You are currently on other investigational treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCemiplimab

Cemiplimab will be administered at a dose of 350mg intravenous over 30 minutes every 3 weeks for 3 cycles (cycle length is 21 days) at weeks 1, 4, and 7.

DRUGXL092

XL092 will be administered at a dose of 60mg PO daily for 8 weeks (weeks 1-8)


Locations(2)

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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NCT06902376


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