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Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT04238624•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Exclusion Criteria

•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
+12 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

January 20, 2020

Primary Completion Date

June 20, 2026

Completion Date

June 20, 2026

Last Updated

July 2, 2025

Enrollment

ACTUAL participants

Conditions

Anaplastic Thyroid CancerThyroid CancerBRAF Gene MutationBRAF Mutation-Related Tumors

Interventions

Dabrafenib

DRUG

Trametinib

DRUG

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT06316895

Papillary Thyroid Cancer

View study

RECRUITINGPHASE2

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

NCT07092514

Thyroid CancerCancer of the Thyroid

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer

RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer

Adjuvant Radiotherapy in High Risk Locally Advanced DTC

Natural History Study of Children and Adults With Medullary Thyroid Cancer