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 range18 Years
SexALL
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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…