Immunotherapy for Soft Tissue Sarcoma: The NEXIS Trial

NEXIS Trial Brochure

Download the brochure (PDF).

Immunotherapy – harnessing the body’s immune system to recognize and destroy cancer cells – has revolutionized the treatment of some cancers such as melanoma and lung cancer. The NEXIS trial seeks to understand if immunotherapy drugs can help patients with certain kinds of soft tissue sarcoma tumors.

It is thought that immunotherapy could have an effect on any sarcoma cells that have already been released into the bloodstream before a patient has had surgery to remove the sarcoma tumor. These cells that have spread from the tumor are what cause sarcoma to come back for some patients. By targeting these cells, immunotherapy might be able to reduce the chance that a patient’s cancer will return.

NEXIS stands for Neoadjuvant XRT Immunotherapy Surgery for Soft Tissue Sarcoma. The trial name means that radiation therapy and immunotherapy are given to patients before surgery to remove the tumor. The NEXIS trial is available at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center in Baltimore.

How Immunotherapy Works

The body’s immune system usually recognizes and destroys cells that are foreign or abnormal. However, cancer cells use defense mechanisms to trick the immune system into thinking they are normal cells. Cancer tumors grow and spread because they go undetected by the immune system.

Most patients with soft tissue sarcoma in one part of the body are diagnosed before separate tumors have developed in their lungs or other organs. Radiation and surgery can destroy and remove the main tumor, but they do not have a major effect on the cancer cells that may have already been released into the bloodstream. These released cells can later develop into additional tumors, even after the primary tumor has been treated.

The two immunotherapy drugs involved in the NEXIS trial are Durvalumab and Tremelimumab. Each of them targets a way that cancer cells use to inactivate T cells, or the body’s primary immune cells. When cancer cells are no longer able to inactivate T cells, it is hoped that the immune system can do its job of getting rid of the foreign invader cancer cells. 

What the NEXIS Trial Involves

Patients enrolled in the NEXIS clinical trial will be treated with the standard treatment for soft tissue sarcoma (radiation followed by surgery). In addition, they will receive three doses of immunotherapy (Durvalumab and Tremelimumab) during the weeks they are undergoing radiation. The patients will then undergo surgery to remove their primary sarcoma tumor. After surgery, depending on whether or not they have any remaining detectable disease, they will receive four or nine doses of Durvalumab. 

Who Is Conducting This Trial

Participants will be treated by specialists on the multidisciplinary University of Maryland Bone Cancer and Soft Tissue Sarcoma Service at the NCI-designated University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) and at the Maryland Proton Treatment Center in Baltimore.

The NEXIS trial is led by principal investigator Vincent Y. Ng, MD. Dr. Ng is an Assistant Professor of Orthopaedics at the University of Maryland School of Medicine. He is also a Musculoskeletal Tumor Surgeon at UMGCCC and is highly experienced in treating soft tissue sarcomas. Trial co-investigators include Dr. William Regine, Dr. Ken Miller, Dr. Edward Sausville, Dr. Paul Staats and Dr. Eduardo Davila.

To learn more about this clinical trial, visit umgccc.org/sarcomatrial or call Navid Saeidi at 410-428-6465.