Anaplastic Thyroid Cancer study: Cemiplimab vs XL092
Official title XL092 and Cemiplimab in BRAF WT Thyroid Cancer
ClinicalTrials.gov ID: NCT06902376
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine being studied as a potential treatment for anaplastic thyroid cancer. is designed to help the immune system recognize and attack cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if it is safe to give two drugs together before surgery. It also looks at how well the treatment works in people with a specific gene change.
- Who it's for
- People with anaplastic thyroid cancer that has a specific BRAF gene mutation.
- What's involved
- Participants will receive two drugs, XL092 and cemiplimab, before having surgery to remove the tumor.
- Time commitment
- The study involves treatment before surgery, but the total time and number of visits are not specified.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- people 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.
You likely can't join if
- Pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study).
- Patients who have had prior exposure to any immune modulating agents or any type of small molecule kinase inhibitor (including investigational...
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments...
- Replacement therapy (e.g.: thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not...
- 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...
See the full eligibility criteria
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- people 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...
- 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.
- Pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study).
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chapel Hill, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.