A Pilot Study of Cemiplimab Immunotherapy Combined with Dabrafenib and Trametinib in People with Persistent Anaplastic Thyroid Cancer

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Full 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

Purpose

Dabrafenib plus trametinib is a standard treatment for BRAF-mutant anaplastic thyroid cancer. If the cancer no longer responds, however, there are no other treatments proven to be effective. In this study, researchers are assessing the safety and effectiveness of adding the immunotherapy drug cemiplimab to dabrafenib and trametinib in patients with BRAF-mutant anaplastic thyroid cancer that is no longer responding to dabrafenib and trametinib alone.

When dabrafenib and trametinib are given to people whose cancers have mutations (changes) in the BRAF gene, the drugs prevent proteins made by the altered genes from sending signals to cancer cells. Without those signals, cancer cells stop growing and spreading. Cemiplimab works by blocking a protein called PD-1 that normally acts as a brake on the immune system. Blocking this protein is like releasing the brake, so the immune system can target cancer cells and destroy them.

Cemiplimab is used to treat a form of skin cancer; its use in this study is considered investigational. Researchers believe that receiving dabrafenib and trametinib will make cancer cells more sensitive to cemiplimab immunotherapy. Dabrafenib and trametinib are taken orally (by mouth) and cemiplimab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic anaplastic thyroid cancer that contains a BRAF V600E mutation.
  • Patients may not have a medical history that prohibits them from receiving immunotherapy, such as a history of receiving an organ transplant.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-608-3776.

Protocol

19-464

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators