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.
Name: Dabrafenib
Name: Trametinib
Description: Response and progression will be evaluated by using criteria proposed in RECIST 1.1.
Measure: Overall Response Rate per RECIST 1.1 Criteria Time: 2 yearsAllocation: N/A
Single Group Assignment
There is one SNP
Response and progression will be evaluated by using criteria proposed in RECIST 1.1.. 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 --- V600E ---
Sherman) - Active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) - History of primary immunodeficiency - History of allogeneic organ transplant - Known history of previous clinical diagnosis of active tuberculosis (this does not include a history of being PPD positive) 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 --- V600E ---