A Phase II Study of Lenvatinib and Pembrolizumab Immunotherapy in People with Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers


Full Title

A Phase II Study of Lenvatinib Plus Pembrolizumab in Patients with Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma and Other Salivary Gland Cancers


The purpose of this study is to see if treatment with both lenvatinib and pembrolizumab is effective for advanced adenoid cystic carcinoma (ACC) and other salivary gland cancers that have come back and/or spread to other parts of the body. Research in other cancers has shown that combining lenvatinib with pembrolizumab may be a promising treatment.

Pembrolizumab is a form of immunotherapy. It boosts the power of the immune system to find and kill cancer cells and is used to treat multiple types of cancer. Lenvatinib works by blocking certain proteins that help cells grow and develop blood vessels. In this study, researchers are testing the idea that in patients with some tumors, lenvatinib may help orient the immune system to respond to pembrolizumab more effectively and better eliminate cancer cells. Lenvatinib is used to treat advanced thyroid cancer and kidney cancer.

The use of pembrolizumab and lenvatinib in patients with ACC and other salivary gland cancers is considered investigational. Pembrolizumab is given intravenously (by vein) and lenvatinib is taken orally (by mouth).

Who Can Join

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

  • Patients must have ACC or other salivary gland cancer that came back or spread despite prior therapy.
  • At least 4 weeks must pass between the completion of previous treatments and the beginning of the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 about this study and to inquire about eligibility, please contact Dr. Alan Ho at 646-608-3774.




Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID