A Phase II Study of Lenvatinib plus Pembrolizumab Immunotherapy in Patients with Radioactive Iodine-Resistant Thyroid Cancer

Full Title

Combination Targeted Therapy with Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers: A Phase II Study

Purpose

Radioactive iodine (RAI) is the standard treatment for thyroid cancer. But in some patients, the thyroid cancer does not absorb enough RAI to shrink. Doctors are therefore seeking better therapies for such RAI-resistant thyroid cancer.

In this study, researchers are assessing the safety and effectiveness of combining the drug lenvatinib with pembrolizumab immunotherapy in patients with RAI-resistant thyroid cancer. Lenvatinib is already used to treat this disease; it works by inhibiting the growth of the blood vessels that tumors need to grow and spread. Pembrolizumab inhibits a protein cancers use to evade detection by the immune system. By inhibiting this protein, it boosts the power of the immune system to find and kill cancer cells. There have been several studies with other cancers that suggest these two drugs work better together than either one does as a single agent.

Pembrolizumab is used to treat several types of cancer; its use in this study is considered investigational. It is given intravenously (by vein) every three weeks, while lenvatinib is taken orally (by mouth).

Eligibility

There are two separate cohorts that are being evaluated in this study. To be eligible, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent inoperable or metastatic differentiated thyroid cancer that continues to grow or came back despite radioactive iodine.
  • At least 2 weeks must pass between completion of any therapies other than lenvatinib and entry into the study.
  • For Cohort 1: Patients may not have previously received a tyrosine kinase inhibitor (such as lenvatinib, sorafenib, cabozantinib, or pazopanib).
  • For Cohort 2: Patients must have only been treated with lenvatinib, and the cancer is starting to grow. In this cohort, patients may have also been treated with one other tyrosine kinase inhibitor in the past.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Eric Sherman at 646-888-4234.

Protocol

17-203

Phase

II

Investigator

Co-Investigators

Diseases