Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer
A Pilot Study of the Addition of Cemiplimab, an Antibody to PD-1, to the Treatment of Subjects With BRAF-Mutant Anaplastic Thyroid Cancer Who Are No Longer Responding to Dabrafenib and Trametinib
1 other identifier
interventional
16
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2020
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2020
CompletedFirst Submitted
Initial submission to the registry
January 21, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2026
July 2, 2025
July 1, 2025
6.4 years
January 21, 2020
July 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate per RECIST 1.1 Criteria
Response and progression will be evaluated by using criteria proposed in RECIST 1.1.
2 years
Study Arms (1)
BRAF-mutant ATC
EXPERIMENTALParticipants will have a diagnosis of BRAF-V600E mutant Anaplastic Thyroid Cancer
Interventions
Eligibility Criteria
You may qualify if:
- 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 creatinine clearance \>/=50 mL/min
- Left ventricular ejection fraction greater than or equal to instutional lower limit of normal (LLN) by echocardiogram or multigated acquisition (MUGA)
- +3 more criteria
You may not qualify if:
- Previous documentation or current evidence of treatment with dabrafenib and trametinib.
- ° Exception: (1) Patients who started dabrafenib and tranetinib for ATC at an institution outside of MSK are eligible or (2) with the consent of the PI (Sherman). However, this exception is limited to 8 subjects.
- Active brain metastases, unless an exception is granted by the Principal Investigator.
- Current interstitial lung disease or pneumonitis
- Prior history of idelalisib therapy. Exceptions allowed with the consent of the principal investigator (Dr. Sherman)
- History of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
- ° History of RVO or CSR or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension)
- History or current evidence of cardiovascular risk, including any of the following:
- Left ventricular ejection fraction (LVEF) \<LLN
- A QT interval corrected for heart rate using the Bazett's formula of QTcB\>/=480msec
- Current evidence of clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for \>30 days before enrollment are eligible)
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months before treatment
- Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection, which will be allowed)
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with trametinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
- Uncontrolled intercurrent illness that would limit compliance with study requirement.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Sherman, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2020
First Posted
January 23, 2020
Study Start
January 20, 2020
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
June 20, 2026
Last Updated
July 2, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.