Recruiting
Phase 1

XL092 & Cemiplimab

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06902376

Conditions

Anaplastic Thyroid Cancer

Thyroid Cancer

BRAF Mutation-Related Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cemiplimab

XL092

Study Details

Brief 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

Study ID

NCT06902376

Start date

Jun 3, 2025

Status verified date

Sep, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Pathologic findings supporting the clinical impression of anaplastic thyroid cancer. Terminology consistent or suggestive of diagnosis may include the following: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.
  • Subject is willing to have a fresh biopsy at least 3 days prior to neoadjuvant therapy if archival tissue is unavailable. Also willing to have a biopsy at the time of SOC surgery, if applicable.
  • Must have BRAF V600E mutation-negative tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue or genetic/molecular testing of the tumor.

Exclusion Criteria:

  • 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.
  • Subject history of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments.
  • Subject is receiving prohibited medications or treatments as listed in the protocol that cannot be discontinued/replaced by an alternative therapy within 7 days of initiating treatment.
  • Participation in another clinical study with an investigational product during the last 3 weeks.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: neoadjuvant XL092 and cemiplimab

Subjects with BRAFV600E wild type (WT) anaplastic thyroid cancer (ATC) who are scheduled to undergo surgical resection as part of their standard of care will receive neoadjuvant XL092 and cemiplimab. Adjuvant therapy may be indicated based on surgical pathology.

Interventions

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.

XL092

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

Primary outcome measure

  • Complete gross resection [ Time Frame: 12 weeks ]
  • Non-hematologic treatment related adverse events (TRAEs) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Rose Hall

1-(919) 966-0808rose_hall@med.unc.edu

Lori Stravers

1-(919) 966-4432lori_stravers@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Siddharth Sheth, MD

Siddharth.sheth@med.unc.edu

Rebecca B Rambharose

(919)-966-4432rebecca_rambharose@med.unc.edu

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • neoadjuvant chemotherapy
  • neoadjuvant immunotherapy
  • standard of care
  • BRAF V600E-WT ATC
  • XL092
  • cemiplimab
  • receptor tyrosine kinase inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-08.