Pivotal Trial of Envafolimab
Research type
Research Study
Full title
A PIVOTAL TRIAL OF ENVAFOLIMAB, AND ENVAFOLIMAB IN COMBINATION WITH IPILIMUMAB, IN PATIENTS WITH ADVANCED OR METASTATIC UNDIFFERENTIATED PLEOMORPHIC SARCOMA OR MYXOFIBROSARCOMA WHO HAVE PROGRESSED ON PRIOR CHEMOTHERAPY
IRAS ID
1004109
Contact name
Charles Theuer
Contact email
Sponsor organisation
TRACON Pharmaceuticals, Inc.
Eudract number
2021-004319-22
Clinicaltrials.gov Identifier
Research summary
This is a pivotal phase 2 study for patients with rare type of sarcoma - Undifferentiated Pleomorphic Sarcoma (UPS) and Myxofibrosarcoma (MFS).
Undifferentiated Pleomorphic Sarcoma (UPS) is a rare type of cancer that begins mostly in the soft tissues of the body. Soft tissues connect, support and surround other body structures. UPS usually occurs in the arms or legs. Less often it can happen in the area behind the abdominal organs (retroperitoneum). Myxofibrosarcoma (MFS) is a type of cancer that typically appears as a slow-growing, painless lump on one of the legs or arms.
The purpose of this research study is to determine the effectiveness and safety of envafolimab, an experimental drug that is not approved for use, when given alone or in combination with ipilimumab to stimulate the immune system to attack cancer cells. Both drugs are monoclonal antibodies, which are substances the body makes as part of an immune response (the body’s response to infection or something foreign to the body). Both drugs are designed to boost immune response against cancer cells by overriding checkpoints that prevent immune cells from attacking cancer cells.
In studies of sarcoma patients with UPS or MFS, checkpoint inhibitors targeting the PD-1/PD-L1 checkpoint have produced long lasting tumour responses when given alone or given with ipilimumab. While envafolimab has been given to more than 700 cancer patients this is the first time envafolimab will be given in combination with ipilimumab.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0377
Date of REC Opinion
19 Jan 2022
REC opinion
Further Information Favourable Opinion