Study of Cemiplimab Combined With Dabrafenib and Trametinib for Anaplastic Thyroid Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT04238624
This clinical trial is exploring whether adding the drug cemiplimab to the standard treatment of dabrafenib and trametinib can effectively treat anaplastic thyroid cancer.
Patient Parameters
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Program Overview
The purpose of this study is to determine if adding cemiplimab to the usual treatment with dabrafenib and trametinib can help control anaplastic thyroid cancer. Researchers want to see if this combination is more effective than the standard treatment alone.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with anaplastic thyroid cancer that has a specific BRAF-V600E mutation.
- Cancer must be either spread to other parts of the body or cannot be surgically removed.
- A doctor should confirm that the cancer cannot be removed by surgery.
- Must have at least one tumor that can be measured by scans or exams.
- Must be 18 years or older.
- Must be in good general health, able to perform daily activities with minimal restrictions.
- Must be able to swallow pills.
- Must have normal blood and organ function based on specific medical tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study.
- Must agree to have 2-4 biopsies of the cancer.
- Must understand and agree to sign a consent form to participate.
Exclusion Criteria
- Have previously been treated with dabrafenib and trametinib, unless specific exceptions apply.
- Have active cancer spread to the brain, unless approved by the study doctor.
- Have lung diseases like interstitial lung disease or pneumonitis.
- Have a history of certain eye conditions like retinal vein occlusion.
- Have heart problems, such as uncontrolled arrhythmias or recent heart attacks.
- Have active hepatitis B or C infections.
- Have HIV and are on antiretroviral therapy.
- Have other serious illnesses that would prevent following the study requirements.
- Cannot receive immunotherapy due to past severe reactions or active autoimmune diseases.
- Have a history of organ transplants or active tuberculosis.
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