Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer (NCT04238624) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer
United States16 participantsStarted 2020-01-20
Plain-language summary
This study is being done to see if adding the study drug, cemiplimab, to the standard therapy with dabrafenib and trametinib is an effective treatment against anaplastic thyroid cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathological (histologically or cytologically) proven diagnosis of BRAF-V600E mutant ATC (a diagnosis that is noted to be consistent with ATC is acceptable)
* Either Metastatic disease or locoregional disease that is considered not resectable for cure
* Ideally a surgeon should determine that the disease is not resectable for cure, but this can also be done by any investigator
* Patients must have measurable disease according to RECIST 1.1 criteria, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as \>/= 20 mm with conventional techniques or as \>/= 10 mm with spiral CT scan, MRI, or calipers by clinical exam
* Age \>/= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \</= (or Karnofsky performance score \>/= 60)
* Able to swallow and retain orally administered medication
* Patient must have normal organ and marrow function as defined below:
* Absolute neutrophil count \>/=1.5 x 10\^9/L
* Hemoglobin \>/=8 g/dL
* Platelets \>/=100 x 10\^9/L
* Serum bilirubin \</=1.5x institutional ULN (unless the patient has GIlbert's Disease, in which case total bilirubin \</=3x institutional ULN)
* AST and ALT \</=2.5x institutional ULN (\</=5x institutional ULN if there is liver metastasis)
* Serum creatinine \</=1.5mg/dL or calculated creatinined clearance (Cockcroft-Gault formula) \>/=50 mL/min or 24-h urine…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.