Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

  • STATUS
    Recruiting
  • End date
    Jun 20, 2024
  • participants needed
    15
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 4 October 2022
ct scan
cancer
measurable disease
metastasis
neutrophil count
anaplastic thyroid carcinoma

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.

Details
Condition Anaplastic Thyroid Cancer, Thyroid Cancer, BRAF Gene Mutation, BRAF Mutation-Related Tumors
Treatment Dabrafenib, Trametinib
Clinical Study IdentifierNCT04238624
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 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
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
childbearing potential. Women of childbearing potential and men must agree to
Ability to understand and willingness to sign a written informed consent document. Note: Use of Legally Authorized Representative (LAR) is permitted
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

Exclusion Criteria

Previous documentation or current evidence of treatment with dabrafenib and trametinib
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)
° Exception: (1) Patients who started dabrafenib and tranetinib for ATC at an
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 RVO or CSR or predisposing factors to RVO or CSR (e.g
History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months before treatment
uncontrolled glaucoma or ocular hypertension)
Uncontrolled intercurrent illness that would limit compliance with study requirement
Inability to receive immunotherapy for the following reasons
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
Active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
potential for pharmacokinetic interactions with trametinib. In addition, these patients are
at increased risk of lethal infections when treated with marrow-suppressive therapy
History of primary immunodeficiency
History of allogeneic organ transplant
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)
Known history of previous clinical diagnosis of active tuberculosis (this does
not include a history of being PPD positive)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note