Anaplastic Thyroid CancerPhase 2NCT04238624
Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer
A Phase 2 study testing Dabrafenib and Trametinib in people with Anaplastic Thyroid Cancer and Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Thyroid Cancer, Thyroid Cancer, BRAF Gene Mutation
- What is being tested?
- Dabrafenib and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jan 2020to 20 Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
- Negative pregnancy test (serum or urine) within 14 days of registration for women of childbearing potential. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Men treated or enrolled on this protocol must also agree to use adequate contraception before the study, for the duration of study participation, and for 4 months after completion of trametinib administration
- Must agree to allow 2-4 separate biopsies of any malignant lesion. For patients whose biopsies (initial) are deemed as unsafe or contraindicated, they will not be eligible.
- Ability to understand and willingness to sign a written informed consent document. Note: Use of Legally Authorized Representative (LAR) is permitted
Who cannot join
- 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):
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- ° 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.
- Inability to receive immunotherapy for the following reasons:
- Any prior grade >/=3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent or any unresolved irAE grade >1
- Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Exceptions allowed with the consent of the principal investigator (Dr. 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: 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
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.
- Conditions
- Anaplastic Thyroid Cancer, Thyroid Cancer, BRAF Gene Mutation, BRAF Mutation-Related Tumors
- Being tested
- Dabrafenib, Trametinib
- Keywords
- Anaplastic Thyroid Cancer, Thyroid Cancer, Cemiplimab, BRAF-Mutant Anaplastic Thyroid Cancer, BRAF Mutation-Related Tumors, BRAF Gene Mutation, 19-464, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Participants will receive dabrafenib 150 mg orally twice a day
TrametinibDrug
Participants will receive trametinib 2 mg orally once a day
| Study group | Role | What they receive |
|---|---|---|
| BRAF-mutant ATC | Experimental | Participants will have a diagnosis of BRAF-V600E mutant Anaplastic Thyroid Cancer Receives: Drug: Dabrafenib; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate per RECIST 1.1 Criteria
Response and progression will be evaluated by using criteria proposed in RECIST 1.1.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start20 Jan 2020
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Sherman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238624
- Sponsor's protocol ID
- 19-464
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.