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XL092 and Cemiplimab in BRAF WT Thyroid Cancer

NCT06902376 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-05

No results posted yet for this study

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).

Conditions

  • Anaplastic Thyroid Cancer
  • Thyroid Cancer
  • BRAF Mutation-Related Tumors

Interventions

BIOLOGICAL

Cemiplimab

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.

DRUG

XL092

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

Sponsors & Collaborators

Principal Investigators

  • Siddharth Sheth, DO MPH · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2028-03-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902376 on ClinicalTrials.gov