A Pilot Study of Lenvatinib Plus Pembrolizumab Immunotherapy in Patients with Advanced Sarcoma

The purpose of this study is to learn whether combining lenvatinib and pembrolizumab is a safe and effective treatment for patients with metastatic soft tissue sarcomas that cannot be surgically removed. This study will include patients with leiomyosarcoma, undifferentiated pleomorphic sarcoma, vascular sarcomas (including angiosarcoma and epithelioid hemangioendothelioma), bone sarcomas (osteosarcoma and chondrosarcoma), malignant peripheral nerve sheath tumor, and synovial sarcoma.

Pembrolizumab is a form of immunotherapy that boosts the power of the immune system to detect and destroy cancer cells. Lenvatinib blocks proteins called tyrosine kinases which help cells grow and develop new blood vessels. Blocking these proteins may slow the growth of cancer cells and cut off the blood supply that feeds them.

Pembrolizumab is used to treat a variety of cancers and lenvatinib is used to treat thyroid cancer; their use in this study is investigational. Pembrolizumab is given intravenously (by vein) and lenvatinib is taken orally (by mouth).

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

• Patients must have inoperable metastatic leiomyosarcoma, undifferentiated pleomorphic sarcoma, vascular sarcoma (including angiosarcoma and epithelioid hemangioendothelioma), bone sarcoma (osteosarcoma and chondrosarcoma), malignant peripheral nerve sheath tumor, or synovial sarcoma that continues to grow despite at least one but no more than three prior regimens of chemotherapy, immunotherapy, targeted therapy, or biological therapy.
• At least 3 weeks must pass between the completion of prior treatment and receipt of the study medications.
• 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. Sandra P. D’Angelo at 646-888-4159.

A Pilot Study of Lenvatinib and Pembrolizumab Immunotherapy in People with Advanced Soft Tissue Sarcoma | Memorial Sloan Kettering Cancer Center (mskcc.org)