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Anaplastic Thyroid CancerPhase 1NEO-COMBATXLNCT06902376

XL092 and Cemiplimab in BRAF WT Thyroid Cancer

A Phase 1 study testing Cemiplimab and XL092 in people with Anaplastic Thyroid Cancer and Thyroid Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab and XL092
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
3 Jun 2025to 31 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rose Hall contact

1-(919) 966-0808

rose_hall@med.unc.edu

Lori Stravers contact

1-(919) 966-4432

lori_stravers@med.unc.edu

United States2 sites, 2 recruiting

  • Dana Farber/Harvard Cancer Center

    Boston, Massachusetts, 02215

    Veronica Bedard, 617-582-7323

    Theodora Pappa, MD, PhD, 617-732-5666, theodora_pappa@dfci.harvard.edu

    Not yet recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Siddharth Sheth, MD, Siddharth.sheth@med.unc.edu

    Rebecca B Rambharose, (919)-966-4432, rebecca_rambharose@med.unc.edu

    Recruiting

Other trials in United States

About this study

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

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).

Read the detailed description

This study includes subjects with BRAFV600E wild type (WT) anaplastic thyroid cancer (ATC) who are scheduled to undergo surgical resection as part of their standard of care. The study hypothesizes that the combination of neoadjuvant XL092 and cemiplimab will be safe and feasible prior to surgical resection in participants with BRAF V600E-WT ATC.

Anaplastic thyroid cancer (ATC) is a highly aggressive and fatal malignancy. For patients with BRAF V600E-wildtype ATC, chemotherapy, whether as a single agent or in combination, remains the standard treatment despite its low response rates. Studies have shown that while immunotherapy (IO) and receptor tyrosine kinase inhibitor (TKI) monotherapy are safe for these patients, their efficacy as single agents is limited.

This study addresses a significant unmet need and is based on the strong synergy observed between IO and TKI in clinical studies of other cancers. It includes subjects with BRAF V600E-wildtype ATC who are scheduled for surgical resection as part of their standard care. The study hypothesizes that the combination of neoadjuvant XL092 and cemiplimab will be safe and feasible before surgical resection in these patients.

Being tested
Cemiplimab, XL092
Keywords
neoadjuvant chemotherapy, neoadjuvant immunotherapy, standard of care, BRAF V600E-WT ATC, XL092, cemiplimab, receptor tyrosine kinase inhibitor
Medical subject headings
Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabBiological

    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.

  • XL092Drug

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

Study groups in NCT06902376
Study groupRoleWhat they receive
neoadjuvant XL092 and cemiplimabExperimentalSubjects 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.
Receives: Biological: Cemiplimab; Drug: XL092

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete gross resection

    Complete gross resection (CGR) is defined as the proportion of patients who undergo successful thyroidectomy with negative (R0) or microscopically positive (R1) surgical margins.

    Measured: 12 weeks

  2. Non-hematologic treatment related adverse events (TRAEs)

    Non-hematologic treatment related adverse events (TRAEs) with neoadjuvant and maintenance XL092 and cemiplimab will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI- CTCAE) v5.0.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Objective response rate (ORR) following neoadjuvant therapy prior to surgery as defined as a partial or complete response per Radiographic response will be measured by RECIST, 1.1 criteria. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: 10 weeks

  2. Time to surgery

    Time to surgery following completion of neoadjuvant XL092 and cemiplimab will be defined as the time from completion of neoadjuvant therapy to date of surgery. Participants who do not receive surgery due to progressive disease or non-treatment-related adverse events death will not be counted.

    Measured: 12 weeks

  3. The rate of pathologic response

    The rate of pathologic response will be defined as either a pathological complete response (pCR), which is the absence of a residual viable tumor or a major pathological response (MPR), which is < 10% residual tumor following neoadjuvant therapy and surgery.

    Measured: 12 weeks

  4. Conversion rate from unresectable to resectable disease

    Conversion rate from unresectable to resectable disease will be defined as the number of subjects with unresectable disease at the time of screening who are deemed to have resectable disease at the completion of neoadjuvant therapy.

    Measured: 12 weeks

  5. Event free survival (EFS)

    Event free survival (EFS) will be defined as the time of first treatment to an event which may include disease progression, discontinuation of the treatment for any reason, or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria. If a patient has no events, they will be censored at the last known alive date. Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Up to 5 years

  6. Overall survival (OS)

    Overall survival (OS) of participants receiving neoadjuvant XL092 and cemiplimab will be defined as the time from the date of first treatment to death.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start3 Jun 2025
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06902376
Sponsor's protocol ID
LCCC2255
Acronym
NEO-COMBATXL
Status last verified
Oct 2026
First submitted
18 Mar 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cemiplimab and XL092 in people with Anaplastic Thyroid Cancer and Thyroid Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rose Hall (1-(919) 966-0808, rose_hall@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete gross resection (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06902376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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